Apparatus and methods for making coated liners and tubular devices including such liners

ABSTRACT

Apparatus and methods are provided for making coated liners and/or tubular devices including such coated liners. A sleeve may be provided that includes an outer first surface and an inner second surface extending between first and second ends thereof, and a hydrophilic or other coating may be applied to the first. The coated sleeve may be cut between the first and second ends to create opposing edges extending between the first and second ends, and the cut sleeve may be reversed such that the coated first surface defines an inner surface and the opposing edges are disposed adjacent one another, thereby providing a coated liner. Optionally, a tubular structure, e.g., one or more reinforcing layers and/or or outer layers may be attached around the coated liner, thereby providing a tubular device including an inner surface with a desired coating.

This application claims benefit of co-pending provisional applicationSer. Nos. 61/153,295, filed Feb. 18, 2009, 61/223,352, filed Jul. 6,2009, 61/227,745, filed Jul. 22, 2009, and 61/234,311, filed Aug. 16,2009, the entire disclosures of which are expressly incorporated byreference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods formaking catheters, sheaths, or other tubular devices, and, moreparticularly, to apparatus and methods for making coated liners forcatheters, sheaths, or other tubular devices, and catheters, sheaths, orother tubular devices including coated liners.

BACKGROUND

Medical devices, such as catheters, sheaths, or other tubular devices,frequently have one or more inner lumens that partially or fully extendthrough the device. These lumens are routinely exposed to bodily fluidsor tissues and/or interact with other instruments and/or physicianspecified fluids unique to a given device or procedure. Given thedisparate uses of these lumens and subsequent wide variety in desiredperformance attributes, various materials and processes have beendeveloped and explored to impart desired performance attributes. Inspite of a wide variety of materials, including specialty coatings, theprocesses currently known for constructing catheters including desiredperformance attributes are generally limited and are frequentlyprohibitively complicated and/or expensive. For example, applying ananti-thrombogenic coating to the inner surface of a cardiovascularcatheter device or subassembly may require 1) masking undesired parts ofthe catheter from exposure to the coating and/or 2) special curingprocesses like exposure to heat or Ultraviolet (“UV”) light. However,heat may be damaging to other catheter components and/or it may bedifficult to expose inner surfaces of small lumens to UV light even overmodest lengths. Alternatively, constructions may include lubriciousliners and/or hydrophilic coatings. These tedious processes, however,routinely exact compromises that reduce the effectiveness of thematerials used or applied. Furthermore, these processes do not lendthemselves to batch or mass production and therefore lack the associatedbenefits in cost and quality.

SUMMARY

The present invention is directed to apparatus and methods for makingcatheters, sheaths, or other tubular devices. More particularly, thepresent invention is directed to apparatus and methods for making coatedliners for catheters, sheaths, or other tubular devices, and tubulardevices including such coated liners.

In accordance with one embodiment, a tubular device is provided thatincludes a proximal end, a distal end sized for introduction into a bodylumen, and a lumen extending between the proximal and distal ends.Generally, the tubular device includes an inner liner including acoating on an inner surface thereof, the coating imparting one or morepredetermined properties to a wall of the lumen, a reinforcing layersurrounding at least a portion of the liner; and an outer layersurrounding the reinforcing layer and inner liner.

In one embodiment, the liner may include multiple sections havingdifferent properties than one another, adjacent sections being attachedtogether by seams, and the outer layer may also include multiplesections having different properties than one another. If desired, theadjacent sections of the outer layer may be attached together by seamsthat are spaced apart axially from seams of the inner liner, e.g., tostagger the seams and/or provide smoother transitions on the distal endof the tubular member.

Optionally, the tubular device may include a distal tip attached to thedistal end of the tubular device, the distal tip including an outertubular layer surrounding a coated liner without a reinforcing layer.The materials of the distal tip may have different properties than themultiple sections of the inner liner and outer layer, e.g., havingDurometers that are substantially softer than the adjacent sections ofthe distal end of the tubular device. For example, in one embodiment,the coated liner of the distal tip may comprise material that is softerthan a distal-most section of the inner liner of the distal end and/orthe outer tubular layer of the distal tip may comprise material that issofter than a distal-most section of the outer layer of the distal end.

In addition or alternatively, the multiple sections of the inner linermay include a relatively soft distal-most section and a relatively lesssoft shaft section attached to the distal-most section by a first seam.The first seam may be substantially orthogonal or non-orthogonal to alongitudinal axis of the tubular device. Alternatively, the first seammay include edges of the distal-most section and the shaft section thatare interlocked with one another.

Similarly, the multiple sections of the outer layer may include aplurality of transition sections adjacent one another on the distal endand a shaft section that extends proximally from the transitionsections. For example, the transition sections may include a firstdistal-most transition section, and a second transition section attachedto the first transition section, the first transition section having alower Durometer than the second transition section. Optionally, thetransition sections may also include a third transition section attachedbetween the second transition section and the shaft section, the secondtransition section having a lower Durometer than the third transitionsection.

In an exemplary embodiment, the multiple sections of the inner liner maycomprise different color materials, e.g., to facilitate identifyingtransitions between the multiple sections.

In accordance with another embodiment, a tubular device is provided thatincludes a proximal end, a distal end sized for introduction into a bodylumen, and a lumen extending between the proximal and distal ends. Thetubular device may include an inner liner including a coating on aninner surface thereof, the coating imparting one or more predeterminedproperties to a wall of the lumen, a reinforcing layer surrounding atleast a portion of the liner, and an outer layer surrounding thereinforcing layer and inner liner. The inner liner may include multiplesections attached together, wherein the multiple sections comprisesdifferent color materials to facilitate identifying transitions betweenthe multiple sections, different Durometers, and/or differentthicknesses.

In accordance with yet another embodiment, a tubular device is providedthat includes a proximal end, a distal end sized for introduction into abody lumen, a lumen extending between the proximal and distal ends, anda distal tip attached to the distal end. The tubular device includes aninner liner comprising a coating on an inner surface thereof, thecoating imparting one or more predetermined properties to a wall of thelumen. The liner also includes a transition section extending proximallyfrom the distal tip, and a shaft section attached to the transitionsection, the transition section having different properties than theshaft section. In addition, the tubular device includes a reinforcinglayer surrounding the liner; and an outer layer surrounding thereinforcing layer and inner liner. The outer layer may include one ormore transition sections extending proximally from the distal tip and ashaft section attached to a proximal-most of the one or more transitionsections. The distal tip may include an outer tubular layer surroundinga coated liner without a reinforcing layer, the material of the distaltip being softer than the transition sections of the inner liner andouter layer.

Optionally, the transition and shaft sections of the inner liner may beattached together at a seam, and adjacent sections of the outer layermay be attached together by seams that are spaced apart axially fromseam of the inner liner. In addition or alternatively, the transitionsection of the inner liner may be softer than the shaft section of theinner liner, and/or the one or more transition sections of the outerlayer may be softer than the shaft section.

In accordance with still another embodiment, a tubular device isprovided that includes a proximal end, a distal end sized forintroduction into a body lumen, and a lumen extending between theproximal and distal ends. The tubular device includes an inner linercomprising a coating on an inner surface thereof, the coating impartingone or more predetermined properties to a wall of the lumen. The innerliner may be formed from an enclosed band wrapped around a mandrel suchthat the inner liner defines a pair of longitudinal seams extendingbetween the proximal and distal ends of the tubular device. In addition,the tubular device includes a reinforcing layer surrounding the liner;and an outer layer surrounding the reinforcing layer and inner liner.

Optionally, the enclosed band may include multiple sections havingdifferent properties such that the properties of the inner liner varybetween the proximal and distal ends of the tubular device. In additionor alternatively, the outer layer may also include multiple sectionshaving different properties than one another, adjacent sections beingattached together by seams that are spaced apart axially from one ormore seams separating the multiple sections of the inner liner.

In one embodiment, the longitudinal seams of the inner liner may extendsubstantially axially between the proximal and distal ends of thetubular device. Alternatively, the longitudinal seams of the inner linerextend helically between the proximal and distal ends of the tubulardevice. The longitudinal seams of the inner liner may includelongitudinal edges that are spaced apart from one another to define gapswhen the endless band is wrapped around the mandrel, the outer layerbeing reflowed to substantially fill the gaps between the longitudinaledges.

In accordance yet another embodiment, a method is provided for making atubular device sized for introduction into a body lumen. An endless bandof material including a coated surface may be folded such that theendless band defines first and second ends and the coated surface isdisposed inwardly. The first and second ends of the endless band may bestretched or otherwise provided over opposite ends of an elongatemandrel such that the coated surface is disposed inwardly towards themandrel and the endless band wraps partially around the mandrel suchthat longitudinal edges of the endless band extend between the oppositeends of the mandrel. A tubular structure may be attached around theendless band while wrapped around the mandrel, e.g., including areinforcing layer and an outer tubular layer.

After attaching the tubular structure around the wrapped band, theenclosed ends of the endless band may be removed and/or the mandrel maybe removed from the band to provide a tubular device defining a coatedlumen.

In an exemplary embodiment, the endless band may be created by attachingfirst and second ends of a sheet together, mounting the resultingassembly to a coating apparatus, and applying a coating to at least onesurface of the sheet.

In accordance with still another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen thatincludes mounting an endless band to an apparatus that moves the bandalong an enclosed path including one or more coating elements; applyinga coating to at least one of the inner surface and the outer surfaceusing the one or more coating elements; and separating the endless bandinto a plurality of narrower endless bands after applying the coating.

One of the narrower bands may be folded such that the narrower endlessband defines first and second ends and the coating is disposed inwardly.The first and second ends of the narrower band may be stretched orotherwise positioned over opposite ends of an elongate mandrel such thatthe coating is disposed inwardly towards the mandrel and the narrowerendless band wraps partially around the mandrel such that longitudinaledges of the narrower endless band extend between the opposite ends ofthe mandrel. A tubular structure may then be attached around thenarrower endless band while wrapped around the mandrel.

In accordance with another embodiment, a method is provided for making atubular device sized for introduction into a body lumen that includesproviding a sheet of material having first and second ends andlongitudinal edges extending between the first and second ends, andattaching the first and second ends of the sheet together to create anendless band including an inner surface and an outer surface. Theendless band may be mounted to an apparatus that moves the band along anenclosed path including one or more coating elements, and a coating maybe applied to at least one of the inner surface and the outer surfaceusing the one or more coating elements.

In one exemplary embodiment, the coating apparatus may include a drumincluding at least one of an interior surface and an exterior surfacedefining the enclosed path, and the endless band may be mounted to oneof the interior and exterior surfaces of the drum. The coating may thenbe applied by rotating the drum to move the endless band past the one ormore coating elements.

In another exemplary embodiment, the coating apparatus may include aroller assembly including a plurality of rollers defining the enclosedpath, and the endless band may be mounted to the apparatus by extendingthe endless band between the plurality of rollers. The coating may thenbe applied by rotating one or more of the plurality of rollers to movethe endless band along the enclosed path and past the one or morecoating elements.

After coating, the endless band may then be separated into one or moreliner components. For example, in one embodiment, the endless band maybe cut or otherwise separated into one or more strips, and one of thestrips may be wrapped around a mandrel such that the coating is disposedinwardly towards the mandrel. A tubular structure may then be attachedaround the wrapped strip and mandrel.

For example, ends of the strip may be secured to ends of the mandrel,and the strip may be wrapped around the mandrel in a longitudinalconfiguration, wherein longitudinal edges of the strip extend betweenthe ends of the mandrel, e.g., in a longitudinal configuration.Alternatively, the strip may be wrapped helically around the mandrelbetween first and second ends of the mandrel.

In accordance with still another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen thatincludes providing a sheet of material having first and second ends andlongitudinal edges extending between the first and second ends;attaching the first and second ends of the sheet together to create anendless band including an inner surface and an outer surface; mountingthe endless band to an apparatus that moves the band along an enclosedpath including one or more coating elements; and applying a coating toat least one of the inner surface and the outer surface using the one ormore coating elements. The endless band may be separated into aplurality of narrower bands after applying the coating, and each of thenarrower bands may be wrapped around a mandrel such that the coating isdisposed inwardly towards the mandrel and longitudinal edges of the bandextend between ends of the mandrel. A tubular structure may then beattached around each of the wrapped bands.

In accordance with yet another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen thatincludes providing a sheet of material having first and second ends andlongitudinal edges extending between the first and second ends;attaching the first and second ends of the sheet together to create anendless band including an inner surface and an outer surface; mountingthe endless band to an apparatus that moves the band along an enclosedpath including one or more coating elements; and applying a coating toat least one of the inner surface and the outer surface using the one ormore coating elements. The endless band may then be separated into oneor more liner components after applying the coating, and each of theliner components may be wrapped around a mandrel such that the coatingis disposed inwardly towards the mandrel. A tubular structure may thenbe attached around each of the wrapped liner components.

In accordance with still another embodiment, a method is provided formaking one or more liner components for tubular devices sized forintroduction into a body lumen. Initially, a plurality of endless bandsmay be provided, and a coating may be applied to at least a firstsurface of each of the endless bands. Optionally, at least one of theendless bands may be formed from a different material than one or moreother endless bands and/or the coating applied to at least one of theendless bands may be different from a coating applied to one or moreother endless bands. Each of the endless bands may be cut or otherwiseseparated into one or more sheets after applying a coating to each ofthe endless bands. At least one sheet from each of the endless bands maybe attached together to create a composite sheet, and the compositesheet may be used to create a composite liner for a tubular device. Forexample, the composite sheet may be wrapped at least partially around amandrel (alone or along with other composite sheets) to create a linercomponent, and a tubular structure may then be attached around thewrapped composite sheet.

In accordance with another embodiment, a tubular device is provided foraspiration of material from a body lumen that includes a proximal end, adistal end sized for introduction into a body lumen, an aspiration lumenextending between the proximal and distal ends, and a vacuum sourcecoupled to the aspiration lumen. Generally, the tubular device includesan inner liner including a coating on an inner surface thereof, thecoating adapted to decrease resistance to flow of aspirated materialthrough the tubular device and/or decrease the propensity of aspiratedmaterial to clog the aspiration lumen.

In accordance with yet another embodiment, a tubular device is providedfor aspiration of material from a body lumen that includes a proximalend, a distal end sized for introduction into a body lumen, anaspiration lumen extending between the proximal and distal ends, and atransport element within the aspiration lumen. Generally, the tubulardevice includes an inner liner including a coating on an inner surfacethereof, the coating adapted to decrease resistance to flow of aspiratedmaterial through the tubular device and/or decrease the propensity ofaspirated material to clog the aspiration lumen.

In accordance with still another embodiment, the tubular device foraspiration of material from a body lumen may include one or moremacerating elements or cutting elements designed to macerate material tobe aspirated from the body.

In accordance with still another embodiment, the tubular device mayinclude a relatively smaller distal region adapted to track more easilythrough the vasculature, and a relatively larger proximal region adaptedto maximize the diameter of an aspiration lumen.

In accordance with yet another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen.Initially, a sleeve may be provided that includes a first outer surfaceand a second inner surface that extend between first and second ends ofthe sleeve. The first surface may be coated with a coating to impart thefirst surface with one or more desired properties, e.g., a hydrophilicmaterial, an antithrombotic material, an antimicrobial material, ananti-hemolytic material, and/or a drug-eluting material.

The coated sleeve may be cut between the first and second ends to createopposing edges extending between the first and second ends, e.g., bycreating a longitudinal seam that extends substantially parallel to alongitudinal axis of the sleeve. The longitudinal seam may extendpartially or entirely through a wall of the sleeve and/or may extendcontinuously or intermittently between the first and second ends. Thecut sleeve may then be reversed such that the coated first surfacedefines an inner surface of the reversed cut sleeve and the opposingedges are disposed adjacent one another.

Optionally, a tubular structure may be attached around the reversed cutsleeve, thereby providing a tubular device comprising an inner surfacewith the one or more desired properties. For example, in one embodiment,the reversed cut sleeve may be positioned over a mandrel such that theopposing edges are disposed adjacent one another, a tubular structuremay be positioned over the reversed cut sleeve and mandrel, and thetubular structure may be attached to the reversed cut sleeve, e.g., byheating to reflow material of the sleeve and/or tubular structure, bybonding with adhesive, and the like. In an exemplary embodiment, thetubular structure may include a reinforcing layer applied around thereversed cut sleeve and one or more layers of material applied aroundthe reinforcing layer.

In accordance with still another embodiment, a substantially continuousmethod is provided for making tubular devices sized for introductioninto a body lumen. Initially, a sleeve may be provided that includes afirst outer surface and a second inner surface that extend between firstand second ends of the sleeve. For example, the sleeve may be providedon a supply mandrel, e.g., carried by a supply reel or other supplysources. The first surface may be coated with a coating, e.g., afterbeing directed from the supply reel, to impart the first surface withone or more desired properties, e.g., a hydrophilic material, anantithrombotic material, an antimicrobial material, an anti-hemolyticmaterial, and/or a drug-eluting material.

The coated sleeve may be cut between the first and second ends to createopposing edges extending between the first and second ends, e.g., bycreating a longitudinal seam or gap that extends substantially parallelto a longitudinal axis of the sleeve. The cut sleeve may opened byseparating the opposing edges, and, if provided on a supply mandrel, thesupply mandrel may be removed from within the sleeve. The cut sleeve maythen be positioned around an uptake mandrel to reverse the sleeve suchthat the coated first surface is oriented inwardly towards the uptakemandrel and the opposing edges are disposed adjacent one another.

Optionally, a tubular structure may be attached around the reversed cutsleeve, thereby providing a tubular device comprising an inner surfacewith the one or more desired properties. For example, a reinforcinglayer may be applied around the reversed cut sleeve and uptake mandrel,and the resulting assembly may be wrapped around an uptake reel or otherstorage device. In this example, the uptake reel may be subsequentlyintroduced into further processes, e.g., to apply one or more additionallayers around the reinforcing layer. The resulting tubular device may becut or otherwise separated into a plurality of individual tubularbodies, e.g., catheter or lead bodies.

In accordance with yet another embodiment, a method is provided formaking tubular devices sized for introduction into a body lumen from athin-walled sheet that includes an outer first surface, an inner secondsurface, and longitudinal edges extending between first and second ends.The sheet may be secured around a first mandrel such that thelongitudinal edges extend along a longitudinal axis of the first mandreland the first surface is disposed outwardly. In one embodiment, thesheet may be secured around the first mandrel by engaging the sheetalong the longitudinal edges with one or more features on the mandrel.For example, the first mandrel may include an elongate slot that extendslongitudinally along the first mandrel, and the longitudinal edges ofthe sheet may be captured in the slot to secure the sheet around thefirst mandrel. Alternatively, the first mandrel may include ridges orother features that extend longitudinally along the first mandrel, andthe longitudinal edges may be placed over the one or more features suchthat one or more clips may capture the features to engage thelongitudinal edges between the one or more clips and features.

A coating may then be applied to the first surface of the sheet thatimparts the first surface with one or more desired properties. Thecoated sheet may then be removed from the first mandrel and reversed toprovide a coated liner, which may be incorporated into one or moretubular devices.

For example, the coated sheet may be positioned around a second mandrel(which may be the same or different from the first mandrel) such thatthe coated first surface is oriented inwardly towards the second mandreland the longitudinal edges are disposed adjacent one another. One ormore layers may then be attached around the coated sheet to provide acatheter component or other tubular device having a coated lumen.

In accordance with still another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen from athin-walled sleeve that includes an outer first surface and an innersecond surface extending between first and second ends of the sleeve.The sleeve may be secured around a mandrel such that the first surfaceis disposed outwardly, e.g., by engaging one or more clips over one ormore mating features on the mandrel to capture the sleeve between theclip(s) and feature(s). The secured sleeve may be coated, and thenremoved from the mandrel to provide a coated liner, e.g., for storageand/or incorporation into one or more tubular devices.

In accordance with yet another embodiment, a method is provided formaking a tubular device sized for introduction into a body lumen using amandrel including a first end, a second end, and an outer surfaceextending between the first and second ends. For example, the mandrelmay be solid or tubular elongate body or a plate defining the outersurface. A coating material may be applied to the outer surface of themandrel, e.g., by dipping, spraying, rolling, brushing, and the like,without curing the coating material. A substrate, e.g., a sheet orsleeve, may be positioned over the mandrel such that a first surface ofthe substrate contacts the coating material on the outer surface of themandrel. The coating material may be cured through the substrate suchthat the coating material bonds to the first surface of the substrate toprovide a coating having one or more desired properties. The coatedsubstrate may provide a coated liner, which may be incorporated into oneor more tubular devices.

In an exemplary embodiment, the coating material may be cured throughthe substrate. For example, the substrate may be exposed to ultravioletlight and the substrate may be at least partially transparent to theultraviolet light such that ultraviolet light passes through thesubstrate to at least partially cure the coating material. In additionor alternatively, inward pressure and/or heat may be applied to thesubstrate to cure the coating material and/or bond the coating materialto the first surface of the substrate.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1A is a perspective view of an exemplary embodiment of a tubulardevice, including a lumen extending between proximal and distal endsthereof.

FIG. 1B is a cross-sectional view of the tubular device of FIG. 1A,taken along line 1B-1B, showing a coated liner surrounding the lumen andan outer layer surrounding the coated liner.

FIG. 1C is a flow chart showing an exemplary method for making tubulardevices, such as the tubular device of FIGS. 1A and 1B.

FIGS. 2A and 2B are perspective views of a sheet that may be formed intoan endless band that may be used to make one or more liners.

FIGS. 2C and 2D are details showing a method for attaching ends of thesheet of FIGS. 2A and 2B to form an endless band.

FIG. 2E is a detail showing an alternate method for attaching ends ofthe sheet of FIGS. 2A and 2B to form an endless band.

FIGS. 2F-2H are details showing additional alternate methods forattaching ends of the sheet of FIGS. 2A and 2B to form an endless band.

FIGS. 2I and 2J are perspective and side views, respectively, of anexemplary embodiment of an endless band that may be used to make one ormore liners.

FIG. 3A is a schematic of a first exemplary embodiment of an apparatusshowing a process for coating an inner surface of an enclosed band, suchas the band of FIGS. 2I and 2J.

FIG. 3B is a schematic of a second exemplary embodiment of an apparatusshowing a process for coating an outer surface of an endless band.

FIG. 3C is a schematic of a third exemplary embodiment of an apparatusshowing a process for coating an outer surface of an enclosed band.

FIG. 3D is a schematic of a fourth exemplary embodiment of an apparatusshowing a process for coating an inner surface of an endless band.

FIGS. 4A and 4B show an exemplary embodiment of an endless band beingseparated into one or more strips having a coated surface.

FIGS. 5A and 5B are perspective and cross-sectional views, respectively,of a strip from the band of FIGS. 4A and 4B being wrapped around amandrel in a longitudinal configuration with the coated surface orientedinwardly towards the mandrel.

FIGS. 6A and 6B are perspective views and FIG. 6C is a cross-sectionalview of a strip from the band of FIGS. 4A and 4B being wrapped around amandrel in a helical configuration with the coated surface orientedinwardly towards the mandrel.

FIGS. 7A and 7B are perspective and side views, respectively, of anendless band having a coated surface being separated into a plurality ofnarrower endless bands.

FIGS. 7C and 7D are perspective views of a narrow band being disposedaround a mandrel.

FIGS. 7E and 7F are cross-sectional details of the narrow band andmandrel of FIGS. 7C and 7D, showing the narrow band being disposedaround the mandrel.

FIG. 8A-8D are cross-sectional views of a coated sheet on a mandrel,such as that shown in FIG. 5B, having a reinforcing layer and an outerjacket provided around them to make a tubular member having a coatedlumen.

FIG. 9A-9D are cross-sectional views of a coated sheet on mandrel, suchas that shown in FIG. 6C, having a reinforcing layer and an outer jacketprovided around them to make a tubular member having a coated lumen.

FIG. 10A-10D are cross-sectional views of a coated sheet on mandrel,such as that shown in FIG. 7F, having a reinforcing layer and an outerjacket provided around them to make a tubular member having a coatedlumen.

FIG. 11A is a perspective view of another exemplary embodiment of atubular device, including a lumen extending between proximal and distalends thereof.

FIG. 11B is a cross-sectional view of the tubular device of FIG. 11A,taken along line 11B-11B, showing a coated liner surrounding the lumenhaving variable properties along a length of the tubular device.

FIG. 12A is a perspective view of rolls of different liner materialbeing separated into individual sheets to be attached together to form acomposite sheet.

FIG. 12B is a side view of the sheets of FIG. 12A, showing a method forattaching ends of the sheets to form a composite sheet.

FIG. 12C is a detail of an alternate method for attaching ends of thesheets of FIG. 12A to form a composite sheet.

FIG. 12D is a perspective view of the composite sheet resulting from themethod of FIGS. 12A-12B.

FIGS. 12E and 12F are perspective views of the composite sheet of FIG.12D being rolled and having its ends attached together.

FIG. 12G is a detail showing the ends of the composite sheet of FIGS.12E and 12F attached together to provide an endless band.

FIG. 12H is a detail showing a method for attaching the ends of thecomposite sheet of FIGS. 12E and 12F together to form a composite bandin preparation for coating a surface of the composite sheet.

FIGS. 13A and 13B are perspective views of a composite band, e.g.,formed from two sheets, such as that shown in FIG. 12D, and having acoated surface, being separated into separate relatively narrowcomposite bands.

FIGS. 13C and 13D are perspective and cross-sectional views,respectively, of a relatively narrow composite band, such as those shownin FIG. 13B, being wrapped around a mandrel in a longitudinalconfiguration with the coated surface oriented inwardly towards themandrel.

FIG. 13E is a cross-sectional view of the band and mandrel of FIGS. 13Cand 13D with a reinforcing layer provided around the band.

FIGS. 14A and 14B are perspective views of a composite sheet, such asthat shown in FIG. 12D, being separated into separate composite stripsafter having a surface of the sheet coated.

FIGS. 14C and 14D are perspective and cross-sectional views,respectively, of a composite strip, such as that shown in FIG. 14B,being wrapped around a mandrel in a longitudinal configuration with thecoated surface oriented inwardly towards the mandrel.

FIG. 14E is a cross-sectional view of the band and mandrel of FIGS. 14Cand 14D with a reinforcing layer provided around the band.

FIG. 15A is a perspective view of an alternative embodiment of acomposite band including alternating sections having different materialproperties with edges of adjacent sections attached by orthogonaltransitions.

FIG. 15B is a perspective view of another alternative embodiment of acomposite band including alternating sections having different materialproperties with edges of adjacent sections attached by non-orthogonaltransitions.

FIG. 15C is a top view of another alternative embodiment of a saw toothseam that may be provided in a composite sheet.

FIG. 15D is a top view of yet another alternative embodiment of aninterlocked seam that may be provided in a composite sheet.

FIG. 16A is a perspective view of a coated endless band, showing axialcut lines for separating the endless band into a plurality of strips.

FIG. 16B is a perspective view of a coated endless band, showingcircumferential cut lines for separating the endless band into aplurality of narrower endless bands.

FIG. 16C is a perspective view of a coated endless band, showing ahelical cut line for separating the endless band into a singlecontinuous strip.

FIG. 17 is a perspective view of an exemplary embodiment of a tubulardevice for aspiration of material from a body lumen.

FIG. 18 is a cross-sectional view of a tubular device including atransport element.

FIG. 19A is a perspective view of a tubular device including amacerating element.

FIG. 19B is a cross-sectional view of a tubular device includingmultiple parallel macerating elements.

FIG. 19C is a cross-sectional view of a tubular device includingmultiple crossing macerating elements.

FIG. 19D is a cross-sectional view of a tubular device includingmultiple non-parallel macerating elements.

FIG. 20 is a cross-sectional view of a tubular device including arelatively smaller distal region and a relatively larger proximalregion.

FIGS. 21A-21E show another method for making a liner component having acoating on an interior surface thereof.

FIG. 22 shows an outer layer being applied around the liner component ofFIG. 21E.

FIG. 23 is a schematic showing an exemplary apparatus and method forsubstantially continuously making coated liners by reversing externalcoated surfaces of a liner substrate.

FIGS. 23A-23C are cross-sectional details of the coated liner atdifferent stages in the apparatus and method of FIG. 23.

FIG. 24 is a schematic showing another exemplary apparatus and methodfor substantially continuously making coated liners by reversingexternal coated surfaces of a liner substrate.

FIGS. 25A-25E are side views showing a method for making a coated linerfrom a sheet carried by a mandrel.

FIGS. 26A-26C are cross-sectional views of alternative embodiments ofmandrels that may be used to coat a sheet using the method of FIGS.25A-25E.

FIGS. 27A and 27B are cross-sectional views showing a tubular sleevebeing secured to a mandrel for making a coated liner using a methodsimilar to the method of FIGS. 25A-25E.

FIGS. 28A-28D are side views of an exemplary mandrel and substrate,showing another method for making a coated liner.

FIGS. 29A-29C are side views of another exemplary mandrel and substrate,showing yet another method for making a coated liner.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 10 for accessing a body lumen (not shown) and/or fordelivering one or more fluids, agents, and/or instruments (also notshown) within a body lumen. In exemplary embodiments, the apparatus 10may be a guide catheter, a procedure catheter, a sheath, an imagingdevice, or other tubular device sized for introduction into a bodylumen, such as a vessel within a patient's vasculature, a passage withina patient's gastrointestinal tract, urogenital tract, reproductivetract, respiratory tract, lymphatic system, and the like.

Generally, the apparatus 10 is an elongate tubular member including aproximal end 12, a distal end 14 sized for insertion into a body lumen,and a lumen 16 extending between the proximal and distal ends 12, 14.Optionally, the apparatus 10 may include one or more additional lumens(not shown), which may be disposed concentrically around or side-by-sidewith the lumen 16. The lumen 16 may be sized for receiving a guide wire,procedure catheter, cardiac lead, needle, or other instrument (notshown), and/or for delivering fluids or other flowable agents ormaterials therethrough.

Optionally, the distal end 14 may include a tapered, rounded, orotherwise shaped distal tip 15, e.g., to provide a substantiallyatraumatic tip and/or facilitate advancement or navigation throughvarious anatomy. In addition or alternatively, the distal end 14 mayinclude one or more therapeutic and/or diagnostic elements, e.g., one ormore balloons, stents, sensors, electrodes, steering mechanisms, imagingdevices, helical anchors, needles, and the like (not shown), dependingupon the particular intended application for the apparatus 10.

Optionally, the proximal end 12 may include a handle 13 and/or one ormore ports, e.g., port 17 communicating with the lumen 16. In additionor alternatively, the handle 13 and/or proximal end 12 may include oneor more connectors, such as luer lock connectors, electrical connectors,and the like, for connecting other devices (not shown) to the apparatus10, such as syringes, displays, controllers, and the like (also notshown). In addition, the handle 13 may include one or more actuators,such as sliders, buttons, switches, and the like, e.g., for activatingand/or manipulating components (also not shown) on the distal end 14 orotherwise operating the apparatus 10.

With particular reference to FIG. 1B, the apparatus 10 generallyincludes an inner liner 20 surrounding the lumen 16 and an outer layer22 surrounding the inner liner 20. The inner liner 20 may include arelatively thin film, sheet, or other material including an innersurface 21. The inner surface 21 may include a coating 38 having one ormore desired properties, e.g., a predetermined lubricity, hydrophiliccharacteristic, and the like, as described further below.

For example, the liner 20 may be formed from a single layer or multiplelayers of material, e.g., having a thickness between about 0.0001-0.050inch (0.0025-1.25 mm), 0.0001-0.01 inch (0.0025-0.25 mm), 0.0001-0.003inch (0.0025-0.076 mm), or 0.0001-0.0015 inch (0.0025-0.038 mm). Inexemplary embodiments, the liner 20 may be formed from plastics, e.g.,thermoplastics, such as polyether block amide (“PEBAX”), urethane,nylon, and the like, fluoropolymers, such as PTFE, FEP, TFE, and thelike, thermoset, and thermoform plastics, such as polyimide orpolyester, and the like. For example, the liner 20 may be Ether-based orEster-based polyurethane. However, other suitable polymers may also beused, such as nylon (including nylon 6/6, nylon 11, nylon 12, PEBA) andengineered resins (including Zytel, Rilsan, Grilamid, Vestamid, Pebax),polyethylene, polyvinylchloride, fluoropolymers (including PTFE, FEP,PFA, PVDF, THV, ETFE, ECFE), polyethylene terepthalate polyester,polyolefin, polyetheretherketone, polypropylene, polyolefin, silicone,natural and synthetic rubbers, polystyrene, polycarbonate,polymethylmethacrylate, and the like. Alternatively, the liner 20 may beformed from thin metal sheets, such as stainless steel or Nitinol, orcomposite materials. Alternatively, the liner 20 may be formed fromwoven, mesh, or nonwoven materials or fabrics, such as nylon, polyester,Tyvek® (flash-spun high-density polyethylene fiber material), and thelike.

The liner 20 may have a substantially homogenous construction, although,alternatively, the construction may vary along the length to providedesired properties, e.g., as described further below with reference toFIGS. 11A and 11B. For example, the durometer of material may vary alongthe length of the thin film sheet 30. Furthermore, the liner 20 may haveone or more transition regions along its length, transitioning from onedesired construction to another, including from one desired material toanother.

One or more coatings 38 may be applied to the inner surface 21 of theliner 20 during fabrication. In an exemplary embodiment, the coatingincludes a hydrophilic material, such as Polyvinylpyrrolidone, and maybe sprayed or otherwise applied onto the surface 21 during fabricationto apply a substantially uniform thickness coating. However, othersuitable hydrophilic materials may also be used, including poly(ethyleneoxide), poly(propylene oxide), poly(ethylene glycol), poly(n-vinyllactam) polyacrylamide, methylcellulose, hydroxypropyl cellulose,hydroxypropylmethyl cellulose, polyacrylic acids, hydroxyethylmethacrylate, polyvinyl alcohols, polyvinyl ethers, hyaluronan,polyurethanes, silicone hydrogel, soy-based hydrogels, andfluorocarbon-sulfone compounds.

The hydrophilic material may provide a predetermined lubricity on theinner surface 21. Alternatively, other materials may be applied toprovide one or more desired properties on the inner surface 21 e.g.,lubricious, biocompatible, hemocompatible, antithrombotic, procoagulant,antimicrobial, antibiotic, anti-encrustive, pH modulating, growthpromoting, growth inhibiting, antiproliferative, endothelializationpromoting, cell adhesion promoting, MR signal emitting, radiodense,echogenic, catalytic, immune modulating, anti-hemolytic, drug-eluting,drug delivery, and the like.

Following application of the coating 38 on the inner surface 21, e.g.,using any of the apparatus and methods described elsewhere herein, thecoating may be cured, cross-linked, or otherwise processed to increasethe strength of adhesion of the coating 38 to the surface 21, e.g.,using heat, ultraviolet (“UV”) light, chemical processing, and the like,as described further below.

The outer layer 22 may be attached to the inner liner 20, e.g., bylaminating, adhering, adhesive bonding, ultrasonic welding, reflowing orother heating, and the like, as described elsewhere herein.

Optionally, the outer layer 22 may include one or more sublayers (notshown). For example, the outer layer 22 may include a braided or helicalreinforcing layer (not shown) surrounding the inner liner 20 and one ormore tubular layers (also not shown) surrounding the reinforcing layerand/or between the reinforcing layer and the inner liner 20. Inexemplary embodiments, the reinforcing layer may include one or moreround or flat wires, filaments, strands, and the like, e.g., formed frommetal, such as stainless steel, plastic, woven fibers, such as glass,Kevlar, and the like, or composite materials. Materials that may be usedin the outer layer 22 include doped or undoped PEBAX, urethane, nylon(including nylon 6/6, nylon 11, nylon 12, PEBA) and engineered resins(including Zytel, Rilsan, Grilamid, Vestamid), polyethylene,polyvinylchloride, fluoropolymers (including PTFE, FEP, PFA, PVDF, THV,ETFE, ECFE), polyethylene terepthalate polyester, polyetheretherketone,polypropylene, silicone, natural and synthetic rubbers, polystyrene,polycarbonate, polymethylmethacrylate, and the like. Materials may beprimarily selected for optimal mechanical, bonding, and/or otherproperties and subsequently imparted with desired surface properties,for example lubricity, by coating.

Exemplary outer layers that may be included in the apparatus 10 andmethods for making them are disclosed in U.S. Pat. Nos. 4,478,898,4,863,442, 5,217,440, 5,254,107, 5,676,659, 5,811,043, 5,836,926,6,004,310, 6,669,886, 6,837,890, and 6,945,970. The entire disclosuresof these references are expressly incorporated by reference herein.

The outer layer 22 may have a substantially homogenous constructionbetween the proximal and distal ends 12, 14. Alternatively, theconstruction may vary along the length of the apparatus 10 to providedesired properties. For example, the outer layer 22 a at or adjacent theproximal end 12 may be substantially rigid or semi-rigid, e.g.,providing sufficient column strength to allow the apparatus 10 to bepushed from the proximal end 12. In addition, the reinforcing layer orother material in the outer layer 22 may allow the apparatus 10 to betwisted from the proximal end 12, e.g., to rotate the distal end 14within a patient's body. Thus, the distal end 14 of the apparatus 10 maybe manipulated within a patient's body from the proximal end 12 withoutsubstantial risk of buckling and/or kinking. Optionally, the outer layer22 b at or adjacent the distal end 14 may be substantially flexible orsemi-rigid, e.g., to allow the distal end 14 to bend easily or otherwisebe advanced through tortuous anatomy and/or provide a substantiallyatraumatic distal tip 15. Furthermore, the outer layer 22 a, may haveone or more transition regions along its length, transitioning from onedesired construction to another.

In exemplary embodiments, the apparatus 10 may have an outer diameterbetween about half and twenty millimeters (0.5-20 mm), and a lengthbetween about five and one hundred fifty centimeters (5-150 cm). Theinner liner 20 may have a wall thickness between about 0.0001-0.01 inch(0.0025-0.25 mm) and the outer layer 22 may have a wall thicknessbetween about 0.0005-0.2 inch (0.0127-5.08 mm).

Turning to FIG. 1C, an exemplary method is shown for making one or moretubular devices, such as the apparatus 10 of FIGS. 1A and 1B. Initially,at step 40, a sheet of material may be provided, e.g., that may be usedto make the inner liner 20 of the apparatus 10. An exemplary embodimentof a sheet of material 42 is shown in FIGS. 2A and 2B. As shown, thesheet 42 includes first and second ends 44 a, 44 b, longitudinal edges46 a, 46 b extending between the first and second ends 44 a, 44 b, andfirst and second surfaces 48 a, 48 b. In this embodiment, the sheet 42may include a substantially uniform construction, e.g., being formedfrom a single material having a substantially uniform thickness andmechanical properties. Alternatively, the material, mechanicalproperties, thickness, durometer, color, and/or other properties of thesheet 42 may be varied, e.g., along its length between the first andsecond ends 44 a, 44 b, as described further below. Properties of thesheet may be varied to impart desirable properties to a tubular deviceor other apparatus into which the sheet is incorporated as a liner, ormay be varied to aid in fabrication. For example, varying color alongwith other properties may enable easy identification or alignment oftransitions and/or identification of coated surfaces during processingor assembly of the sheet.

Returning to FIG. 1C, at step 50, ends of the sheet intended to createone or more liners may be attached together to create an endless band.For example, as shown in FIGS. 2B-2J, the first and second ends 44 a, 44b of the exemplary sheet 42 are shown being attached together to createan endless band 52. In this example, the first surface 46 a of the sheet42 defines an inner surface of the band 52 and the second surface 46 bdefines an outer surface of the band 52.

With particular reference to FIGS. 2C and 2D, the first and second ends44 a, 44 b may be butted together and attached, for example, by welding(e.g., sonic welding), fusing (e.g., heating, melting, or otherwisereflowing the material), bonding with adhesive, and the like.Alternatively, the ends 44 a, 44 b may be attached together using one ormore fasteners, e.g., staples, clips, threads, tape, and the like (notshown), which may facilitate separating the ends 44 a, 44 b of the sheet42 after processing the endless band 52, if desired. FIG. 2F shows anexemplary embodiment of a heating assembly 54 including first and secondplates 56 a, 56 b that may be used to fuse the butted ends 44 a, 44 b.FIGS. 2E and 2G show an alternative process in which the ends 44 a, 44 bof the sheet 42 are lapped over one another by a desired distance andattached together, e.g., using the heating assembly 54. In eitheroption, the resulting seam may have a substantially uniform thickness,similar to the rest of the sheet 42 creating the band 52, e.g., as shownin FIGS. 2H-2J. Thus, the resulting band 52 may have a substantiallyuniform thickness and/or other substantially homogeneous mechanicalproperties. Alternatively, the thickness of the seam may be greater orotherwise not the same as the rest of the sheet 42, e.g., if the seam isnot intended to be used as part of a liner for a tubular device (notshown) or if the seam is reflowed to a similar thickness to the sheet 42during subsequent processing, e.g., as described elsewhere herein.

Alternatively, an endless band may be created by methods other thanattaching together ends of a sheet. For example, an extruded tube (notshown) may be cut in relatively short lengths and stretched, blown, orotherwise expanded to increase its diameter. Alternatively, an endlessband may be created from multiple relatively narrower endless bands orone or more strips joined with a helical seam, e.g., as described below.

Returning to FIG. 1C, at step 60, the endless band may be mounted to acoating apparatus, e.g., which may define a substantially enclosed path.Once the endless band is mounted to the coating apparatus, at step 70,one or more coatings may be applied to at least one of the inner surfaceand the outer surface of the band using the coating apparatus. Thecoating(s) may be applied to the surface(s) substantially continuously,i.e., by directing the endless band around the enclosed path one or moretimes. A single pass or circuit is completed when any point on theendless band passes from a starting point along the entire length of theenclosed path and returns to the starting point.

For example, FIG. 3A shows an exemplary embodiment of a coatingapparatus 62 that includes a roller assembly including a plurality ofrollers or pulleys 64 and one or more coating elements 66, 68. Therollers 64 may be spaced apart from one another to define asubstantially enclosed path along which the endless band 52 may bemounted and directed. At least one of the rollers 64 may include a motoror other drive mechanism (not shown) for pulling or otherwise directingthe endless band 52 along the enclosed path. In addition, one or more ofthe rollers 64 may be spatially adjustable, for example, movablemanually or automatically relative to the other rollers 64, to adjusttension of the endless band 52, e.g., to maintain a desired tension tofacilitate directing the endless band 52 along the enclosed path. Forexample, as shown in FIG. 3A, a tensioning roller 64 a may apply tensionto the endless band 52 based on its weight or additional added weight(e.g., by gravity), using a spring assembly (not shown), and the like.

The rollers 64 may have a width corresponding to the width of theendless band 52, e.g., between about 0.005 to ninety six inches(0.005-96″), or between about two to twelve inches (2-12″). For example,the width of the rollers 64 may correspond to the circumference ofindividual liners, to the circumference of multiple liners or to thelength of individual liners being formed from the endless band 52.Optionally, the rollers 64 may include sprockets or other features forpositively engaging the endless band 52, although alternatively, thematerial of the rollers 64 may itself allow the endless band 52 to bedirected around the rollers 64 with minimal slippage.

Generally, the coating element(s) include one or more applicators 66 forapplying one or more coating materials to an inner surface 48 a of theendless band 52, and one or more curing devices 68 for curing thecoating material. As shown, the coating apparatus 62 includes a firstapplicator 66 a and curing device 68 a spaced apart along the enclosedpath from a second applicator 66 b and curing device 68 b. Theapplicators 66 may apply the same coating material or differentmaterials, e.g., to provide a multiple layer coating on the endless band52. For example, in one embodiment, the first applicator 66 a may applyan initial coating of hydrophilic material, which may facilitateadhesion and/or uniform coverage or a second coating of hydrophilicmaterial applied by the second applicator 66 b. In another example, thefirst applicator 66 a may apply a first therapeutic agent (e.g., ananti-proliferative agent) and the second applicator 66 b may apply asecond therapeutic agent (e.g., an anti-thrombotic agent) over the firsttherapeutic agent. In still another example, one or more primers may beapplied before applying one or more desired coatings. Alternatively,only a single applicator 66 and curing device 68 may be provided (notshown), for example, to provide a single coating layer, e.g., by passingthe endless band 52 only once past the applicator 66 and curing device68, although multiple layers may also be applied in such a configurationby simply directing the endless band 52 around the enclosed pathmultiple times. In a further alternative, a plurality of applicators 66may be located before a single curing device 68 (not shown).

In exemplary embodiments, the applicator(s) 66 may include one or moresprayers, rollers, brushes, sponges, dipping assemblies, mayer rods,silk screening devices, spin coating devices, plasma coating devices,vapor deposition devices, and the like, e.g., as appropriate to apply adesired coating material to the endless band 52. The curing device(s) 68may include one or more heating elements, sources of ultraviolet light,blowers, humidifiers, dryers, and the like, as appropriate to cure thecoating material applied before the respective curing device 68.Alternatively, one or more of the curing device(s) 68 may be eliminated,e.g., if the coating material cures automatically.

Turning to FIG. 3B, another embodiment of a coating apparatus 62′ isshown, which is generally similar to the coating apparatus 62 shown inFIG. 3A, except that the applicators 66′ and curing devices 68′ arelocated to apply a coating to an outer surface 48 b of the endless band52. Otherwise, the coating apparatus 62′ may include similar componentsand may function similarly to the coating apparatus 62.

Turning to FIG. 3C, still another embodiment of a coating apparatus 162is shown. Generally, the coating apparatus 162 includes a drum or otherrotor 164 including a circumference around which the endless band 52 maybe mounted, and one or more coating elements 166, 168 along the enclosedpath for applying one or more coating materials to an outer surface 48 bof the endless band 52. For example, as shown, the coating elementsinclude two applicators 166 for applying coating material(s) and twocuring devices 168, spaced apart from one another adjacent the drum 164,e.g., in first and second sets similar to the coating apparatus 62,although alternatively, only a single applicator 166 and curing device168 may be provided or multiple applicators and curing devices, asdesired (not shown).

In this embodiment, the endless band 52 may be wrapped around an outersurface 164 a of the drum 164, which may have a fixed diameter and/orcircumference, or may be adjustable to adjust a tension of the endlessband 52 wrapped around the drum 164. In addition or alternatively, theendless band 52 may be stretched slightly to mount the endless band 52around the drum 164, e.g., to secure the endless band 52 around the drum162 by friction. Optionally, the endless band 52 may be substantiallyfixed to outer surface 164 a of the drum 164 using one or more otherfeatures, e.g., a low-tack adhesive, vacuum ports in the drum 164 topull the endless band 52 against the outer surface 164 a, one or morefasteners, e.g., clamps or clips applied along the edges of the endlessband 52, studs or other fasteners that penetrate through the material ofthe endless band 52, magnetic fasteners placed over the endless band 52that are attracted to the drum 164 material, and the like (not shown).

With the endless band 52 mounted to the drum 162, the drum 162 may berotated, thereby directing the endless band 52 along an enclosed pathcorresponding to the circumference of the drum 162. The applicator(s)166 and curing device(s) 168 may be spaced apart in desired sets orconfigurations, similar to those described above to apply and cure oneor more coating materials to the outer surface 48 b of the endless band52.

Turning to FIG. 3D, yet another embodiment of a coating apparatus 162′is shown that includes a drum 164′ and one or more applicators 166′ andcuring devices 168′ similar to the embodiment of FIG. 3C. Unlike theprevious embodiment, however, the endless band 52 may be mounted to aninner surface 164 b′ of the drum 164′ rather than an outer surface. Inthis alternative, fasteners may be needed to removably secure theendless band 52 to the inner surface 164 b.′ Otherwise operation of thecoating apparatus 162′ may proceed similar to the previous embodiment.

The drums 164, 164′ may have a diameter between about twelve and thirtysix inches (12-36″), e.g., at least two inches (2″) to providesufficient space to accommodate applicators, curing devices, and/orother components in or around the drums 164, 164′ or as large as tenfeet (10′) in diameter to facilitate large production quantities. Thedrums 164, 164′ may be formed from substantially rigid materials, e.g.,a continuous fixed cylinder defining the outer or inner surfaces 164 a,164 b.′ Alternatively, the drums 164,164′ may include a plurality ofplates, each defining a portion of a cylinder, that are arrangedadjacent one another to approximate the enclosed path, e.g., with one ormore of the plates being movable radially inwardly or outwardly toadjust the circumference of the enclosed path to correspond to theperiphery of the endless band being coated and/or otherwise adjusttension of the endless band 52.

Optionally, after any of the coating processes just described, thecoated band 52 may be cured or otherwise treated. For example, thecoated band may be placed in a chamber and heated, exposed toultraviolet light, and the like to further cure the coating and/or treatthe material of the endless band 52. Alternatively, the endless band 52may remain on the drum 164, 164′ after coating and subjected tosubsequent processing. For example, the drum 164, 164′ may be removedfrom a drive axle (not shown) of the coating assembly 162, 162′ andmoved to another axle or device (not shown), e.g., for additional curingor processing. If desired, the subsequent axle or device may be in anenvironmental chamber to subject the endless 52 band to desiredenvironmental conditions, e.g., heat, pressure, and/or humidity,compared to those used during the initial coating process. In anexemplary embodiment, a coating may be applied and partially cured usingthe coating assembly 162, 162′ and the drum 164, 164′ and coated bandmay be transferred to an oven (not shown) for additional curing.

Returning to FIG. 1C, at step 80, the endless band 52 may be separatedinto one or more liner components. For example, in FIG. 4A, an endlessband 52′ is shown that has a width corresponding to a circumference of adesired liner. The band 52′ may be cut, e.g., between its longitudinaledges to provide a relatively long, narrow strip 82,′ as shown in FIG.4B. Alternatively, the band 52′ may have a width greater than individualliners, and may be cut into multiple narrow strips, as described furtherelsewhere herein.

Alternatively, as shown in FIG. 7A, an endless band 52 having a widththat is substantially greater than the circumference of a desired linermay be separated into a plurality of relatively narrower bands 82, asshown in FIG. 7B. For example, the endless band 52 may be cut using aplurality of cutting elements 85, shown schematically in FIG. 7A. Thecutting elements may include a plurality of blades, wires, lasers, orother cutters capable of cutting through the material of the endlessband 52. In one embodiment, the endless band 52 may be foldedsubstantially flat, as shown in FIG. 7A, and directed past an array ofcutting elements 85 that substantially simultaneously cut the endlessband 52 into the narrower bands 82. Alternatively, narrower bands 82 maybe cut from the endless band 52 sequentially using a single cuttingelement (not shown).

Turning to FIGS. 16A-16C, the endless band 52 may be separated intoliner components in different configurations. For example, as shown inFIG. 16A, an endless band 52 may be cut or otherwise separated alongaxial cut lines 56 to create multiple strips 58. In this embodiment, thewidth of the endless band 52 corresponds to the lengths of the strips58, e.g., which may correspond to the length of one or more liners beingformed from the strips 58.

Alternatively, in FIG. 16B, the endless band 52 may be cut or otherwiseseparated along circumferential cut lines 56′ to create multiplerelatively narrow bands 58.′ In a further alternative shown in FIG. 16C,the endless band 52 may be cut or otherwise separated along a helicalcut line 56″ to create a single continuous strip 58.″ Such a continuousstrip 58″ may be useful for making a plurality of tubular devices usinga substantially continuous process, as described elsewhere herein.Alternatively, these processes may be reversed to create an endless bandfrom two or more relatively narrower endless bands or one or morestrips. For example, one or more circumferential seams (not shown) maybe created between two or more relatively narrow bands 58′ to create anendless band 52. Alternatively, a helical seam (not shown) may becreated between one or more strips 58″ to create an endless band 52. Anendless band 52 created in this manner may be further coated, separatedinto liner components, or otherwise processed as described elsewhereherein.

In yet another alternative, one or more endless bands 52 may be cut orotherwise separated into one or more sheets, such as those depicted inFIG. 12A, and subsequently joined to form a single composite sheet 152such as that shown in FIG. 12D having different properties along itslength, as described further below. The sheet 152 may then be furtherseparated into one or more liner components, also as described furtherbelow.

Returning to FIG. 1C, at step 90, one or more liner components createdfrom the endless band may be formed into one or more liners and/ortubular devices. Generally, this involves wrapping each liner componentaround a mandrel, e.g., such that the coating is disposed inwardlytowards the mandrel. Thereafter, at step 100, a tubular structure may beattached around the wrapped liner component and mandrel, e.g., toprovide one or more tubular devices, such as the tubular device 10 shownin FIGS. 1A and 1B.

For example, turning to FIG. 4A-5B, an exemplary method for creating acoated liner is shown. As explained above, FIG. 4A shows an exemplaryembodiment of an endless band 52′ including a coated surface 48 a′ andFIG. 4B shows the endless band 52′ cut to provide an elongated strip 82′including a coated surface 83.′ The endless band 52′ may have beenformed and coated using any of the processes described above, or mayhave been created by separating a wider endless band (not shown) into aplurality of bands similar to band 52.′ For example, a relatively wideendless band may be cut to provide a coated sheet, and then the sheetmay be cut into individual strips, similar to strip 82.′ For example,the coated sheet may be directed through an array of cutters, e.g.,blades or wires, laser devices, and the like (not shown), thatsimultaneously creates a plurality of strips from the coated sheet.

With additional reference to FIGS. 5A and 5B, the strip 82′ may have awidth “w” corresponding to a circumference of a liner to be formed usingthe strip 82′. More particularly, the width “w” of the strip may besubstantially the same as the circumference of a mandrel 92. The strip82′ may have a length equal to or greater than a length of the mandrel92 such that ends 84′ of the strip 82′ may be disposed adjacentrespective ends 94 of the mandrel 92, e.g., such that longitudinal edges86′ of the strip 82′ extend axially, e.g., substantially parallel to alongitudinal axis of the mandrel 92. As best seen in FIG. 5B, the strip82 may then be wrapped around the mandrel 92 until the longitudinaledges 86′ are disposed adjacent one another. For example, as shown inFIG. 5B, the inner most corners of the longitudinal edges 86′ maycontact one another or may be spaced slightly apart from one another(not shown), while the outer most corners of the longitudinal edges 86′are spaced apart from one another. Thus, the strip 82′ may be wrappedaround the mandrel 92 without the longitudinal edges 86 overlapping.Alternatively, the width “w” of the strip 82′ may be slightly smallerthan the circumference of the mandrel 92 such that a narrow gap (notshown) remains between the longitudinal edges 86′ after wrapping thestrip 82′ around the mandrel 92. Alternatively, the longitudinal edges86′ may be modified such that any gap does not define a substantiallystraight line between the ends 84′ of the strip 82.′ For examplelongitudinal edges 86′ may be cut in a sine-wave or zigzag pattern (notshown) such that one edge mirrors the other when the strip 82′ ispositioned around the mandrel 92.

Optionally, the ends 84′ of the strip 82′ may be secured relative to themandrel 92. For example, in one embodiment, the ends 94 of the mandrel92 may be pointed, and the ends 84′ of the strip 82′ may be hooked atleast partially around the ends 94 of the mandrel 92, e.g., stretchingthe strip 82′ to apply a slight tension along the length of the strip82′ between the ends 84.′ Such tension may enhance maintaining the strip82′ wrapped around the mandrel 92 and/or aligning the longitudinal edges86′ along the mandrel 92.

Turning to FIGS. 8A-8D, the strip 82′ wrapped around the mandrel 92 maybe used to make a tubular device 102, which may be similar to tubulardevice 10 shown in FIGS. 1A and 1B. For example, as shown in FIGS.8A-8C, a reinforcing layer 104 and an outer layer 106 may be placedaround the strip 82,′ e.g., surrounded by a section of heatshrink tubing108. The entire assembly may be heated to reflow the outer layer 106,e.g., which may flow inwardly through the reinforcing layer and bond tothe strip 82′, filling any gap between the longitudinal edges 86′ of thestrip 82.′ Exemplary methods for making tubular devices includingreinforcing layers and outer layers are disclosed in U.S. Pat. Nos.7,550,053 and 7,553,387, the entire disclosures of which are expresslyincorporated by reference herein.

Returning to FIG. 1C, once the tubular device 102 of FIGS. 8C and 8D ismade, at step 110, the mandrel 92 may be removed, along with theheatshrink tubing 108. The resulting tubular device 102 thus includes alumen 103 surrounded by a coated liner defined by strip 82.′ If thetubular device 102 has a length greater than a desired catheter or otherfinished device, the tubular device 102 may be separated into one ormore devices at step 112. This may simply involve cutting the tubulardevice 102 into desired lengths, or any desired additional featuresdesired for the finished device, such as those described above, may beadded to the individual tubular devices 102, e.g., a relatively softdistal tip, a handle, a valve, a shape-set to the distal end, an outerdiameter coating, one or more radiopaque markers, and the like (notshown).

Alternatively, the tubular device 102 may be made using a substantiallycontinuous process. For example, if the endless band 52′ in FIG. 4A issufficiently long, the resulting strip 82′ shown in FIG. 5A may be woundonto a reel and the like (not shown). The wound strip and reel may thenbe mounted on a spindle or other feature of an automated apparatuscapable of feeding the strip along with other components of the tubulardevice 102 substantially continuously. Thus, the strip 82′ may be usedto make a sufficiently long tubular device 102 that may be separatedinto as few as one or as many as hundreds or thousands of tubularbodies, e.g., by substantially simultaneously feeding components of thetubular bodies from sources, such as reels, through the apparatus untilthe sources are depleted, whereupon new source(s) may be loaded onto theapparatus and the process continued. Thus, the apparatus and methodsdescribed herein may be used to make relatively long tubular bodies,e.g., that are substantially longer than finished catheters or othertubular devices. Exemplary apparatus and methods for such substantiallycontinuous fabrication are disclosed in U.S. Publication No.2009/0126862, published May 21, 2009, the entire disclosure of which isexpressly incorporated by reference herein.

Returning to FIGS. 4A and 4B, with additional reference to FIGS. 6A-6C,another method is shown for creating a liner component. Similar to themethod of FIGS. 5A and 5B, a strip 82′ may be provided from an endlessband 52′ (shown in FIGS. 4A and 4B). Rather than wrap the strip 82′around a mandrel 92 in a longitudinal configuration, the strip 82′ maybe wound helically around a mandrel 92, as shown in FIGS. 6A and 6B. Inthis embodiment, the width “w” of the strip 82′ may not bear anyparticular relationship to the size of the mandrel 92, other than beingnarrower than the length of the mandrel 92 such that the strip 82′ iswrapped one or more times around the mandrel 92. For example, the strip82′ may be wound around the mandrel 92 with a single rotation of threehundred sixty degrees (360°) or less, e.g., between one half and onefull rotation, or may be wound multiple times around the mandrel 92. Thestrip 82′ may be wound such that the longitudinal edges 86′ of the strip82′ are disposed adjacent one another along adjacent windings withoutoverlap. The edges 86′ may contact one another, e.g., butt up againstone another, as shown in FIG. 6C, or may be spaced slightly apart, ifdesired (not shown). Alternatively, the longitudinal edges 86′ mayoverlap one another (not shown), and the material of the strip 86′ maybe reflowed during subsequent processing to provide a substantiallyuniform thickness wall liner, if desired. Optionally, the helicallywound strip 82′ (or any of the other strips described herein) mayinclude a composite coated liner, e.g., as described elsewhere herein.

As shown in FIGS. 9A-9D, the helically wound strip 82′ may beincorporated into a tubular device 102,′ e.g., including a reinforcinglayer 104 and an outer layer 106, similar to the embodiment of FIGS.8A-8D. The resulting tubular device 102′ may include a coated lumen 103′similar to the tubular device 102, except that the seam from the strip82′ extends helically down the length of the tubular device 102′ ratherthan axially as in the device 102.

Turning to FIGS. 7A-7F, another embodiment of a method for making linercomponents is disclosed. As explained above, an endless band 52 may becreated that includes a coating on at least one of the inner and outersurfaces, e.g., inner surface 48 a. The endless band 52 may be cut orotherwise separated into a plurality of narrower endless bands 82, asshown in FIG. 7B. For example, as shown in FIG. 7A, an array of cutters85 may be provided that are spaced apart from one another by a distancecorresponding to the desired width of each of the narrower endless bands82, as described elsewhere herein. Alternatively, the narrower endlessbands 82 may be formed sequentially by passing the endless band 52multiple times through a cutting device (not shown) that creates one ormore narrower endless bands 82 at a time.

Each narrower endless band 82 may be wrapped around a mandrel 92 withthe coated surface 83 oriented inwardly towards the mandrel 92. Forexample, as shown in FIGS. 7C and 7D, the narrower endless band 82 maybe flattened and ends 84 of the band 82 may be received over respectiveends 94 of the mandrel 92. The length of the flattened band 82 and themandrel 92 may be such that the band 82 may be stretched slightly toreceive the ends 84 over the ends 94 of the mandrel 92, e.g., to apply aslight tension along the length of the band 82. As shown in FIGS. 7E and7F, the band 82 may wrap around the mandrel 92 such that longitudinaledges 86 of the band 82 are disposed adjacent one another and extendsubstantially axially between the ends 94 of the mandrel 92.Alternatively, if desired, the ends 84 of the band 82 may be rotatedabout the longitudinal axis of the mandrel 92 relative to one another,e.g., such that the longitudinal edges 86 of the band 82 extendhelically between the ends 94 of the mandrel 92 (not shown).

Each narrower endless band 82 may have a width having a desiredrelationship with a circumference of a liner to be formed using thenarrower endless band 82. More particularly, the width of the narrowerendless band 82 may be substantially half or slightly less than half thecircumference of mandrel 92. Thus, as shown in FIG. 7F, the inner mostcorners of the longitudinal edges 86 may contact one another or may bespaced slightly apart from one another (not shown), while the outer mostcorners of the longitudinal edges 86 are spaced apart from one another.Thus, the narrower endless band 82 may be wrapped around the mandrel 92without the longitudinal edges 86 overlapping.

Alternatively, the width “w” of the narrower endless band 82 may beslightly smaller than half the circumference of the mandrel 92 such thata narrow gap (not shown) remains between the longitudinal edges 86 afterwrapping the narrower endless band 82 around the mandrel 92. Such a gapmay reduce the likelihood of the edges 86 of the narrower endless band82 shifting and overlapping. In a further alternative, the longitudinaledges 86 may overlap, and the material of the band 86 may be reflowedduring subsequent processing to provide a substantially uniformthickness wall liner, if desired (not shown).

Alternatively, multiple narrower endless bands (not shown) may bewrapped around the mandrel 92. The width “w” of each narrower endlessband may be substantially equal to c/2n, where “c” is the circumferenceof the mandrel 92 and n is the number of narrower endless bands used.Alternatively, the width “w” of each of the multiple narrower endlessbands (not shown) may be greater than or less than c/2n, resulting inoverlaps or narrow gaps, respectively, similar to other embodimentsdescribed elsewhere herein.

Optionally, the ends 84 of the narrower endless band 82 may be rotatedrelative to one another, e.g., to wind the band 82 helically around themandrel 92. In this option, the longitudinal edges 86 may provide a gap,may be butted together, or may be spaced apart, similar to otherembodiments described elsewhere herein.

Turning to FIGS. 10A-10D, the narrower endless band 82, wrapped aroundthe mandrel 92, may be incorporated into a tubular device 102,″ e.g.,including a reinforcing layer 104 and an outer layer 106, similar to theembodiments of FIGS. 8A-9D. Optionally, after applying a reinforcinglayer 104 and/or outer layer 106 around the narrower endless band 82wrapped around the mandrel 92, the ends of the tubular device 102″ maybe trimmed or otherwise cut to length (not shown), as desired. Theresulting tubular device 102″ may include a coated lumen 103″ similar tothe tubular devices 102, 102,′ except that the band 82 creates a pair oflongitudinal seams that extend down the length of the tubular device102.″ The longitudinal seams may extend axially or helically dependingupon whether the ends 84 of the band 82 are rotated relative to oneanother or not.

Turning now to FIGS. 11A and 11B, another embodiment of a tubular device210 is shown that may be made using the apparatus and methods describedherein. Generally, the tubular device 210 is an elongate tubular memberincluding a proximal end 212, a distal end 214 sized for insertion intoa body lumen, and a lumen 216 extending between the proximal and distalends 212, 214. The distal end 214 may terminate in a relatively softand/or substantially atraumatic distal tip 215, as described furtherbelow. Optionally, the apparatus 210 may include one or more additionallumens, a handle and/or one or more ports, or other elements (notshown), similar to other embodiments described herein.

With particular reference to FIG. 11B, the apparatus 210 generallyincludes an inner liner 220 surrounding the lumen 216 and an outer layer222 surrounding the inner liner 220, e.g., including a reinforcing layer224 and an outer tubular layer 226. Similar to the previous embodiments,the inner liner 220 may include a relatively thin film, sheet, or othermaterial including an inner surface 221, and the inner surface 221 mayinclude a coating 238 having one or more desired properties, e.g., ahydrophilic coating.

Unlike the previous embodiments, the inner liner 220 may have acomposite construction, e.g., formed from one or more sections ofmaterial 220 a-220 c having different properties than one another. Inaddition, the outer tubular layer 226 may also be formed from one ormore sections of material 226 a-226 e, also having different propertiesthan one another. Optionally, one or more of the seams 227 a, 227 bbetween the adjacent sections 220 a-220 c of the inner liner 220 may beoffset axially from one or more of the seams 229 a-229 d betweenadjacent sections 226 a-226 e of the outer tubular layer 226.

For example, as shown in FIG. 1B, the distal tip 215 of the tubulardevice 210 may include a relatively soft material for both the outertubular layer 226 and the inner liner 220, and the reinforcing layer 224may terminate before the distal tip 215. In an exemplary embodiment, theinner liner 220 may include a distal-most section 220 a formed from arelatively soft material, e.g., forty Durometer (40 D) polyurethane, anda distal-most section 226 a of the outer tubular layer 226 may be formedfrom a relatively soft material, e.g., a thirty five Durometer (35 D)PEBAX, which optionally may be doped with Tungsten or Barium.

The distal tip 215 including sections 220 a, 226 a may be formedseparately from the rest of the tubular device 210, e.g., using a lay-upprocess in which a tube (corresponding to section 226 a of the outertubular layer 226) may be lined with a thin sheet (corresponding tosection 220 a of the inner liner 220) and then separated into multiplelengths that provide tips for multiple devices. Additional informationon methods for making such tips are disclosed in the applicationsincorporated by reference elsewhere herein.

Adjacent the distal tip 215, the inner liner 220 may include atransition section 220 b, e.g., formed from fifty five Durometer (55 D)polyurethane or other material more rigid than the distal-most section220 a, and then a shaft section 220 c, e.g., formed from seventy twoDurometer (72 D) PEBAX or other material more rigid than the more distaltransition section 220 b, which may extend from the distal end 214 ofthe tubular device 210 to the proximal end 212. Similarly, the outertubular layer 226 may include one or more transition sections 226 b-226d (three shown) and a shaft section 226 e, which may extend proximallytowards the proximal end 212 of the tubular device 210. In theembodiment shown, the seams 229-229 d of the outer tubular layer 226 areoffset axially or staggered from the seam 227 b of the inner liner 220,which may provide smoother stiffness transitions along the length of thedistal end 214. Such smoother transitions may reduce the risk of thedistal end 214 buckling or kinking, e.g., when the tubular device 210 isdirected through tortuous anatomy.

In an exemplary embodiment, the transition sections 226 b-226 d of theouter tubular liner 226 may be formed from progressively more rigidmaterial in sections away from the distal tip 215. For example, thefirst transition section 226 b may be formed from forty Durometer (40 D)PEBAX, which optionally may be doped similar to the distal-most section226 a, the second transition section 226 c may be formed from fifty fiveDurometer (55 D) PEBAX, and the third transition section 226 d may beformed from sixty three Durometer (63 D) PEBAX. The shaft section 226 emay be formed from nylon or Pebax, or other material, similar to theexemplary embodiments described elsewhere herein.

The tubular device 210 may be incorporated into a variety of catheters,sheaths, or other medical devices. In an exemplary embodiment, thetubular device 210 may be incorporated into a catheter for deliveringcardiac leads into a patient's heart (not shown). In such an example,the tubular device 210 may have a length between about thirty and sixtyfive centimeters (30-65 cm), and an outer diameter between about fourand ten French (4-10 Fr). The proximal end 212 of the tubular device 210may include a handle or hub (not shown), which may include a portcommunicating with the lumen 216, e.g., including a hemostatic valve(also not shown), which may provide a substantially fluid-tight seal,while accommodating insertion of leads or other instruments or fluidsinto the lumen 216. Optionally, the distal end 214 of the tubular device210 may be shape set in a desired configuration, e.g., biased to asimple or complex curved shape, e.g., as disclosed in the applicationsincorporated by reference elsewhere herein.

Turning to FIGS. 12A-12H, an exemplary method is shown for makingcomposite coated liners for tubular devices, such as tubular device 210.As shown in FIG. 12A, a plurality of different materials may beprovided, e.g., material A, material B, and material C, which may be cutinto sheets that may be attached together to provide a composite sheet242, as shown in FIG. 12D. For example, materials A, B, C may be cut orotherwise separated into individual sheets 242 a, 242 b, 242 c havingdesired lengths, e.g., corresponding to the length of respectivesections of one or more liners to be formed from the composite sheet242. The sheets 242 a, 242 b, 242 c may have widths corresponding to thewidth of an individual liner component or to multiple liner components,similar to the previous embodiments.

Adjacent edges of the sheets 242 a, 242 b, 242 c may be attachedtogether at seams 243 a, 243 b. For example, as shown in FIG. 12B, oneor more heating assemblies 254 may be provided for simultaneously orsequentially fusing butted edges of the sheets 242 a, 242 b, 242 c.Alternatively, as shown in FIG. 12C, edges of the sheets 242 a, 242 b,242 c may be lapped over one another by a desired distance and attachedtogether, e.g., using the heating assembly 254. In either option, theresulting seams 243 a, 243 b may have a substantially uniform thickness,similar to the rest of the sheets 242 a, 242 b, 242 c. Thus, theresulting composite sheet 242 may have a substantially uniform thicknessand/or other substantially homogeneous mechanical properties.Alternatively, the thickness of the seams 243 a, 243 b may be greater orotherwise not the same as the rest of the composite sheet 242, e.g., ifthe seams 243 a, 243 b are reflowed during subsequent processing,similar to previous embodiments.

Turning to FIGS. 12E-12H, the composite sheet 242 may then be formedinto an endless band 252, similar to the previous embodiments. As shownin FIGS. 12G and 12H, ends 244 a, 244 b of the composite sheet 242 maybe attached together, e.g., using heating assembly 254. For example, theends 244 a, 244 b may be butted together and attached, for example, bywelding (e.g., sonic welding), fusing (e.g., heating, melting, orotherwise reflowing the material), bonding with adhesive, and the like.Alternatively, the ends 244 a, 244 b may be attached together using oneor more fasteners (not shown), similar to previous embodiments, whichmay facilitate separating the ends 244 a, 244 b of the composite sheet242 after processing the endless band 252, if desired.

In an alternative embodiment, shown in FIG. 15A, an endless band 252′may be formed from multiple composite sheets 242.′ For example,materials A, B, C may be cut into identical sheets 242 a,′ 242 b,′ 242c′ whose edges may be attached together in an alternating or sequentialpattern. Thus, the sheets from each material may have the same lengthand width, although the lengths of the different material sheets may bedifferent, similar to the previous embodiment. The resulting endlessband 252′ may be used to make multiple liner components, e.g., with theendless band 252′ having a width corresponding to the individual linercomponents or multiple liner components.

In the embodiment shown in FIG. 15A, the seams 243′ between the adjacentsheets 242′ may be substantially orthogonal, e.g., perpendicular, to thelongitudinal edges of the endless band 252.′ Alternatively, as shown inFIG. 15B, an endless band 252″ may be provided that includes multiplesheets 242″ whose adjacent edges are attached to define non-orthogonalseams 243.″ For example, the seams 243″ may extend laterally relative tothe longitudinal edges of the endless band 252.″ Turning to FIG. 15C,another alternative embodiment of a seam 243′″ is shown that includes asaw tooth shape, e.g., by interlocking saw tooth edges of the adjacentsheets 242.′″ Finally, FIG. 15D, shows yet another alternativeembodiment of an interlocked seam 243′″ that may be provided, ifdesired. Such non-orthogonal and/or interlocked seams may providesmoother transitions between dissimilar materials that an orthogonalseam.

Returning to FIGS. 13A-13E, any of these composite endless bands maythen be coated using any of the apparatus and methods describedelsewhere herein with respect to other embodiments. For example, FIG.13A shows an exemplary endless band 252′ that has had a coating appliedto its inner surface 248 a. Similar to previous embodiments, the endlessband 252′ may be cut or otherwise separated into a plurality ofrelatively narrower endless bands 282, as shown in FIG. 13B, e.g., usingcutting assembly 285 shown in FIG. 13A.

Turning to FIGS. 13C-13E, each of the narrower endless bands 282 may beincorporated into a tubular device, similar to the previous embodiments.For example, as shown in FIG. 13C, a narrower endless band 282 may beflattened and ends 284 of the narrower endless band 282 may be receivedover respective ends 94 of the mandrel 92. In this embodiment, thesheets of the endless band 252′ may be configured to ensure that thesections of the narrower endless bands 282 are symmetrical between ends284. For example, if the intended liner includes three sections frommaterials A, B, C, the endless band 252′ should include two sheets ofeach of these materials oriented opposite one another when the narrowerendless band 282 is flattened, as shown in FIGS. 13A and 13B. Asexplained elsewhere herein, the sheets of the endless band 252″″ may beformed from different colors, which may facilitate identifying thetransitions between the materials to confirm proper orientation of thenarrower endless band 282 before being wrapped around the mandrel 92.

With particular reference to FIG. 13C, similar to the previousembodiments, the length of the flattened band 282 and the mandrel 92 maybe such that the flattened band 282 may be stretched slightly to receivethe ends 284 over the ends 94 of the mandrel 92, e.g., to apply a slighttension along the length of the endless band 82. As shown in FIGS. 13Dand 13E, the endless band 282 may wrap around the mandrel 92 such thatlongitudinal edges 286 of the band 282 are disposed adjacent one anotherand extend substantially axially between the ends 94 of the mandrel 92.Alternatively, if desired, the ends 284 of the endless band 282 may berotated about the longitudinal axis of the mandrel 92 relative to oneanother, e.g., such that the longitudinal edges 286 of the band 282extend helically between the ends 94 of the mandrel 92 (not shown),similar to the previous embodiments.

Each narrower endless band 282 may have a width substantially half orslightly less than half the circumference of mandrel 92. Thus, thenarrower endless band 282 may be wrapped around the mandrel 92 withoutthe longitudinal edges 286 overlapping, similar to the previousembodiments. Alternatively, the width “w” of the narrower endless band282 may be slightly smaller than half the circumference of the mandrel92 such that a narrow gap (not shown) remains between the longitudinaledges 286 after wrapping the narrower endless band 282 around themandrel 92 or the longitudinal edges 286 (not shown), also similar tothe previous embodiments.

Turning to FIG. 13E, the narrower endless band 282, wrapped around themandrel 92, may be incorporated into a tubular device, e.g., including areinforcing layer 104 and an outer layer (not shown), similar to theprevious embodiments.

Turning to FIGS. 14A-14E, another exemplary method is shown for creatinga plurality of liner components and/or tubular devices using the endlessband 252 of FIG. 12F. In FIG. 14A, the endless band 252 has been cut orotherwise separated to provide a composite coated sheet 252.′″ Using thecutting assembly 285, the composite coated sheet 252″′ may be cut orotherwise separated into a plurality of strips 282,′ e.g., as shown inFIG. 14B, which may be formed into individual liner components. If acoated endless band is created that includes multiple sequences ofsheets, such as the endless band 252,′ the individual sections 242′ maybe separated either after cutting the endless band 252′ into narrowerbands or after cutting across the endless band 252′ to create acomposite sheet (not shown), similar to FIG. 14A.

Turning to FIGS. 14C-14E, each of the strips 282′ may then be wrappedaround a mandrel 92, e.g., until the longitudinal edges 286′ of thestrip 282′ are disposed adjacent one another. For example, as shown inFIG. 14E, the inner most corners of the longitudinal edges 286′ maycontact one another or may be spaced slightly apart from one another(not shown), while the outer most corners of the longitudinal edges 86′are spaced apart from one another. Thus, the strip 282′ may be wrappedaround the mandrel 92 without the longitudinal edges 286′ overlapping.Alternatively, the longitudinal edges 286′ may be overlapped, ifdesired, similar to other embodiments herein.

Optionally, the ends 284′ of the strip 282′ may be secured relative tothe mandrel 92, for example, by hooking the ends 284. around the ends 94of the mandrel 92, e.g., stretching the strip 282′ to apply a slighttension along the length of the strip 282.′ The strip 282′ wrappedaround the mandrel 92 may be incorporated into a tubular device, e.g.,including a reinforcing layer 104 and an outer layer (not shown),similar to the previous embodiments.

Turning to FIG. 17, an exemplary embodiment of an apparatus 300 is shownfor aspiration of material (not shown) from a body lumen (not shown).The apparatus 300 includes a tubular device including a proximal end 301and a distal end 302 sized for introduction into a body lumen. Anaspiration lumen 303 extends between the proximal end 301 and the distalend 302. A vacuum source 304 may be coupled to the aspiration lumen 303at its proximal end 301. The aspiration lumen 303 may include an innerliner (not shown) including a coating on an inner surface thereof. Forexample, similar to other embodiments herein, the coating may be adaptedto decrease resistance to flow of aspirated material through the tubulardevice and/or decrease the propensity of aspirated material to clog theaspiration lumen 303. The construction of the apparatus 300, includingany inner liner (not shown), may be similar to any of those describedelsewhere herein. For example the apparatus 300 may include a tubulardevice having an outer layer (not shown) and a braided or helicalreinforcing layer (not shown) surrounding the inner liner (not shown)and one or more tubular layers.

In an exemplary embodiment, the body lumen (not shown) may be a coronaryartery and the material to be aspirated may be at least one of embolicmaterial, thrombus, and plaque. Alternatively, the body lumen (notshown) may be an artery within the neurovasculature. Moreover, the bodylumen (not shown) may be any vein or artery within the body,particularly one that is at least partially occluded by embolicmaterial, thrombus and/or plaque. Alternatively, the body lumen (notshown) may be in other locations where pathologic occlusions may occur,such as the gastrointestinal or urogenital tract.

Aspiration of material from the body lumen (not shown) may beaccomplished using a vacuum source 304, which may be coupled to theaspiration lumen 303 at the proximal end 301 of the tubular device. Inan exemplary embodiment, the vacuum source 304 may be a syringeconnected to a hub 305, for example, by means of a standard luerfitting. When a vacuum is drawn within the syringe, material (not shown)is aspirated from a body lumen (not shown), through the aspiration lumen303, and into the syringe 304. Other sources of vacuum may include avacuum pump, vacuum bottle, wall suction, and other suitable sources.Alternatively, the vacuum source may be made intermittent or oscillatoryin order to decrease the propensity toward clogging. As a furtheralternative, the vacuum may be alternated with pressure for the samepurpose.

As described above, the aspiration lumen 303 may include an inner liner(not show) including a coating on an inner surface thereof. For example,this coating may include a hydrophilic coating adapted to decreasefriction or resistance to flow of material aspirated through the lumen303. Other suitable coatings may be included in order to decreaseresistance, increase flow rate, and/or decrease clogging of the lumen303. For example, an anti-thrombotic coating such as heparin may beused. In addition or alternatively, a fibrinolytic coating such asstreptokinase, urokinase, or tissue-type plasminogen activator may beused. Such coatings may also serve to reduce the size of aspiratedparticles and/or prevent particle aggregation or thrombus formationwithin the lumen 303. As a further alternative, the inner liner (notshown) of the aspiration lumen 303 may include multiple coatings.

Turning to FIG. 18, another exemplary embodiment of an apparatus 325 isshown for aspiration of material (not shown) from a body lumen (notshown). Similar to the previous embodiment, the apparatus 325 includes atubular device including a proximal end (not shown) and a distal end 330sized for introduction into a body lumen. An aspiration lumen 329extends between the proximal end (not shown) and the distal end 330. Theapparatus 325 may include any of the components and features describedelsewhere herein with respect to other embodiments. For example, it mayinclude an inner liner 326 including one or more coatings on the innersurface thereof, a braided or helical reinforcing layer 327 surroundingthe inner liner 326, and one or more tubular layers 333. Furthermore, ifdesired, the apparatus 325 may include a vacuum source (not shown),which may be coupled to the proximal end, similar to the previousembodiment.

Additionally, the apparatus 325 may include a transport element, e.g. amechanism for mechanically moving material from the distal end 330 tothe proximal end (not shown), positioned within and at least partiallyalong the length of the aspiration lumen 329. For example, the transportelement may include an impeller 328 including an inner shaft 331 and ahelical rotor 332, such that when rotated material is moved from thedistal end 330 of the apparatus out of the body. Exemplary transportelements that may be included in the apparatus 325 and methods formaking them are disclosed in U.S. Pat. Nos. 6,454,775, 6,652,548,6,660,014, 6,663,613, 6,702,830, and 6,945,977. The entire disclosuresof these references are expressly incorporated by reference herein.

Optionally, the apparatus 300 or 325 may include a macerating element.The macerating element may be passive or active. For example, turning toFIG. 19A, a wire 351 may be positioned at or near the distal end of anaspiration lumen 352 within a tubular device 350. The aspiration lumen352 may include an inner liner 353, which may include one or morecoatings on the inner surface thereof. The wire 351 may cross thediameter of the aspiration lumen 352 and may be adapted to passively cutand/or separate material as it is drawn into the lumen 352 duringaspiration. The wire 351 may be positioned at the distal tip of thetubular device 350 in order to macerate material just as it enters theaspiration lumen 352. Alternatively, the wire 351 may be positionedsomewhat proximal to the distal tip of the tubular device 352.Alternatively, the wire 351 may be positioned more proximally within thetubular device 350 to macerate, cut, or separate material as it passesthrough the lumen 352, in an effort to prevent clogging or slowing offlow. Further alternatively, multiple wires similar to 351 may be placedalong the length of the tubular device 351. As a further alternatively,one or more wires 351 may be replaced by one or more blades (not shown)or other cutting elements.

FIGS. 19B-D illustrate alternative configurations of wires or blades 351that may serve to macerate material passing through an aspiration lumen.For example, two or more wires or blades 351 may be positionedsubstantially parallel to each other within the aspiration lumen 352, asexemplified in FIG. 19B. Alternatively, two or more wires or blades 351may be positioned not parallel each other within the aspiration lumen352, as exemplified in FIG. 19D. Further alternatively, two or morewires or blades may be positioned to cross one another as exemplified inFIG. 19C.

Exemplary macerating elements, including active macerating elements,that may be included in the apparatus 300 or 325 and methods for makingthem are disclosed in U.S. Pat. Nos. 6,454,775, 6,652,548, 6,660,014,6,663,613, 6,702,830, and 6,945,977. The entire disclosures of thesereferences are expressly incorporated by reference herein.

Turning to FIG. 20, optionally, the apparatus 300 or 325 may include adistal end 375 sized for introduction into a body lumen. An aspirationlumen 376 extends between the proximal end (not shown) and the distalend 375. The aspiration lumen 376 may include an inner liner 377including a coating on an inner surface thereof, the coating adapted todecrease resistance to flow of aspirated material through the tubulardevice and/or decrease the propensity of aspirated material to clog theaspiration lumen 376. Further, the diameter of the distal end 375 andaspiration lumen 376 may vary along the length of the apparatus. Forexample, the most distal region of the distal end 375 may be relativelysmaller than the adjacent region, e.g., to facilitate navigation throughvascular anatomy, while the more proximal region of the apparatus may berelatively larger to maximize the diameter of the aspiration lumen 376and thereby decrease resistance to flow of aspirated material throughthe tubular device and/or decrease the propensity of aspirated materialto clog the aspiration lumen 376.

Turning to FIGS. 21A-21E, another exemplary embodiment of a method formaking coated liners for tubular devices is shown. As shown, one or moreliners 470 may be formed from a sleeve 450 that includes a first outersurface 452 and a second inner surface 454 that extend between a firstend 456 a and a second end 456 b of the sleeve 450. The sleeve 450 maybe formed using similar materials and/or methods to those describedelsewhere herein. For example, the sleeve 450 may include urethane,nylon, engineered plastics, such as PEBAX, vestamid, and the like. Thesleeve 450 may have a length corresponding to an individual coated lineror other tubular body 470 being made using the sleeve 450.Alternatively, the sleeve 450 may have a length substantially greaterthan an individual coated liner, e.g., such that a plurality ofindividual coated liners or other tubular bodies (not shown) may be madefrom the sleeve 450. For example, unlike the bands described elsewhereherein, the sleeve 450 may have a relatively small diameter, e.g.,compared to its length (while a band may have a relatively largediameter, e.g., to facilitate accessing inner surfaces of the band).

In an exemplary embodiment, thermoplastic material may be extruded,dipped, molded, or otherwise formed and/or applied around a mandrel 440having a desired diameter or other cross-section, e.g., corresponding toan inner diameter of a liner or other tubular device being made. Themandrel 440 may be formed from materials sufficiently durable towithstand the parameters used during manufacturing, e.g., heat and/orpressure, and/or may include a coating on its outer surface, e.g., PTFEand the like, that may facilitate removing the sleeve 450 from themandrel 440 after processing and/or inserting the mandrel 440 throughthe sleeve 450 (if not formed thereon). Alternatively, the sleeve 450may be formed separately from the mandrel 440 and the mandrel 440 may beinserted through the formed sleeve 450 to support the sleeve 450 duringcoating and/or other processing. In a further alternative, if the sleeve450 is sufficiently rigid or otherwise self-supporting, the mandrel 440may be omitted and the sleeve 450 may be processed without a supportingmandrel.

With continued reference to FIG. 21A, the first surface 452 of thesleeve 450 may be coated with a coating to impart the first surface withone or more desired properties, e.g., a hydrophilic material, anantithrombotic material, an antimicrobial material, an anti-hemolyticmaterial, a drug-eluting material, and/or any other coating, e.g., asdescribed elsewhere herein. For example, the sleeve 450 carried by themandrel 440 may be dipped in or otherwise drawn through a container ofliquid coating material 480. Alternatively, the sleeve 450 (with orwithout the mandrel 440) may be drawn upwardly through a reservoir ofliquid coating material (not shown). In further alternatives, thecoating may be applied using other processes, such as those describedelsewhere herein, including brushing, rolling, spraying, and the like.

Turning to FIG. 21B, the coated sleeve 450 may be slit or otherwise cutbetween the first and second ends 456, e.g., to create a longitudinalseam, gap, or cut line 458 that extends between the first and secondends 456. For example, a blade, laser, wire, cutting wheel, heatedelement, or other cutter (not shown) may be directed along the sleeve450 between the first and second ends 456 to create the seam 458. Asshown, the seam 458 extends substantially parallel to a longitudinalaxis of the sleeve 450, although alternatively, the seam may extendhelically or otherwise between the first and second ends 456 (notshown). The seam 458 may extend partially or entirely through a wall ofthe sleeve 450 and/or may extend continuously or intermittently betweenthe first and second ends 456.

The cut sleeve 460 may then be inverted, reoriented, or otherwisereversed to provide a coated reversed cut sleeve or liner 470 such thatthe coated first surface 452 defines an inner surface of the liner 470.For example, as shown in FIG. 21C, the cut sleeve 460 may be openedalong the seam 458 such that the cut sleeve 460 includes longitudinaledges 459 that extend between the first and second ends 456. If the seam458 is created by cutting entirely through the sleeve 450 between thefirst and second ends 456, opposing edges 459 may be created when thesleeve 450 is cut. Alternatively, if the seam 458 only extends partiallythrough the wall of the sleeve 450 and/or is intermittent between thefirst and second ends 456, the longitudinal edges 459 may be createdwhen the remaining material along the seam 458 is torn or otherwiseseparated. If the sleeve 450 is carried on a mandrel (such as mandrel440 shown in FIG. 21A, the mandrel may be removed before, when, or afterthe sleeve 450 is opened.

Turning to FIG. 21D, the cut sleeve 460 may then be inverted,reoriented, or otherwise reversed to provide a coated liner 470. FIG.21D shows an intermediate sheet 460 that is created when the opposingedges 459 of the cut sleeve 460 have been completely separated. Thesheet 460 may be rolled around a mandrel (not shown) or other device tocreate the reversed cut sleeve or liner 470 shown in FIG. 21E.Alternatively, the cut sheet 460 may be separated into a plurality ofstrips (not shown), e.g., similar to other embodiments herein, andindividual strips may be rolled around a mandrel to provide a coatedliner. Optionally, if desired, the opposing edges 459 of the liner 470may be attached together to provide a substantially enclosed sleeve ortube (not shown). Alternatively, the opposing edges 459 may remain freebut adjacent to one another, e.g., abutting, overlapping, or spacedslightly apart, before being incorporated into other devices, similar toother embodiments described elsewhere herein.

The resulting coated liner 470 (whether with separate edges or formedinto an enclosed sleeve) may be incorporated into one or more tubularbodies, e.g., one or more catheter or lead bodies, similar to otherembodiments described elsewhere herein. For example, as shown in FIG.22, a tubular structure may be attached around the liner 470, therebyproviding a tubular device 480 including an inner surface 452 with ahydrophilic and/or other coating. For example, in one embodiment, theliner 470 may be positioned over a mandrel (not shown) such that theopposing edges 459 (see FIG. 21D) are disposed adjacent one another, andone or more layers 472, 474 may be applied around the liner 470 toprovide the tubular device 480.

As shown in FIG. 22, a reinforcing layer 472 has been applied around thecoated liner 470 and an outer layer 474 is being positioned over thereinforcing layer 472 and liner 470. In an exemplary embodiment, thereinforcing layer 472 may be wrapped around the liner 470 and mandrel(not shown), and the resulting assembly may be heated, e.g., using heatshrink tubing, direct hot air, a heated external die, and the like (notshown) to at least partially reflow the material of the liner 470, e.g.,to embed the reinforcing layer 472 partially in the liner 470 and/orotherwise bond the reinforcing layer to the liner 470.

The resulting subassembly may be stored for subsequent use or may have atubular structure 474, e.g., including one or more solid wall layers,positioned over and attached to the reinforcing layer 472 and coatedliner 470. For example, an enclosed tubular structure 474 may beinserted over the reinforcing layer 472 and liner 470 or one or morelayers of material may be wrapped or otherwise built up to provide theouter layer 474. The resulting assembly may be heated, e.g., to at leastpartially reflow the material of the liner 470 and/or the outer layer474, may be bonded with adhesive, and the like to provide the tubulardevice 480.

Turning to FIG. 23, an apparatus 510 is shown for making tubular devicesincluding coated inner surfaces, e.g., similar to the coated liner 470,although using a substantially continuous process. As shown, theapparatus 510 includes a supply reel 512 for providing a sleeve 550 orother length of tubular supply material, e.g., on a mandrel 540, anuptake reel 514 for receiving the finished coated liner 570 or othertubular device(s) 580, a slitter or other cutter 516 (shown in FIG. 23A)for cutting the sleeve 550, e.g., after coating, and a plurality ofrollers or other guides 518 for directing the sleeve 550 and/or mandrel540 along the apparatus 510 and/or maintaining sufficient tension toensure substantially continuous operation of the apparatus 510.

Similar to the previous embodiment, the sleeve 550 may include a firstouter surface 552 and a second inner surface 554 that extend betweenends of the sleeve 550 (best seen in FIG. 23A). As shown, the sleeve 550is initially provided on a mandrel 540 to provide a sleeve subassembly,and the sleeve subassembly is carried by the supply reel 512 or othersupply source (not shown). Alternatively, if the sleeve 550 hassufficient rigidity or self-supporting structure, the mandrel 540 may beeliminated and the sleeve 550 may be drawn from the supply reel 512 onits own. In one embodiment, the first surface 552 of the sleeve 550 maybe coated with a coating, e.g., before being loaded onto the supply reel512, as shown. Alternatively, the first surface 552 may be coated afterthe sleeve or sleeve subassembly is directed from the supply reel 512,e.g., at location “A,” which is identified schematically and notnecessarily spatially in FIG. 23. In this alternative, the apparatus 510may include one or more sprayers, dipping tanks, and the like (notshown) that may be used to apply a coating to the first surface 552 and,optionally, one or more curing devices, e.g., heaters, UV light sources,and the like (also not shown), that may apply and/or cure the coating onthe first surface 552 between the supply reel 512 and the cutter 516,similar to other embodiments described elsewhere herein.

At location 23A-23A in FIG. 23, the coated sleeve 550 may be cut alongits length to create a longitudinal seam defined by opposing edges 559that extends substantially continuously along the length of the coatedsleeve 550. For example, as shown in FIG. 23A, a cutter 516, e.g., ablade, laser, wire, cutting wheel, heated element, and the like, may beprovided for creating a substantially continuous seam along the coatedsleeve 550. In one embodiment, the cutter 516 may be incorporated intoroller 518 a shown in FIG. 23, although alternatively, a separate cuttermay be provided adjacent roller 518 a (not shown in FIG. 23).

The apparatus 510 may include multiple rollers 518 b, which mayfacilitate separating the cut sleeve 560 from the mandrel 540, as shownin FIG. 23. For example, the apparatus 510 may maintain sufficienttension to automatically open the cut sleeve 560 into a substantiallyplanar strip, as best seen in FIG. 23B, while directing the mandrel 540out of and away from the cut sleeve 560. Although not shown, theapparatus 510 may include a set of rollers or other tensioning devicesto maintain sufficient tension on the sleeve 550 and/or mandrel 540 asthey are directed along the apparatus 510, similar to other embodimentsdescribed elsewhere herein.

At location 23C-23C in FIG. 23, the mandrel 540 and cut sleeve 560 mayagain be merged together, e.g., such that the cut sleeve 560 may bepositioned around the mandrel 540 to provide an reversed cut sleeve orcoated liner 570. For example, the apparatus 510 may cause the cutsleeve 560 to wrap automatically around the mandrel 540, e.g., byapplying a desired tension, such that the coated first surface 552 isoriented inwardly towards the mandrel 540 and the opposing edges 559 aredisposed adjacent one another, as best seen in FIG. 23C. Thus, the cutsleeve 560 may provide a coated liner 570 around the mandrel 540,similar to the coated liner 470, although liner 570 may have a lengthsubstantially longer than the liner 470.

Optionally, a reinforcing layer 572 may be applied around the coatedliner 570, e.g., before the liner 570 is wound onto uptake reel 514. Forexample, a braiding device (not shown) may be provided for applyingmultiple strands helically or otherwise around the liner 570, which mayfacilitate constraining the liner 570 around the mandrel 540. Exemplaryapparatus and methods for wrapping reinforcing layers around sleeves orstrips are disclosed in U.S. Publication No. 2009/0126862, incorporatedby reference herein. Optionally, at location “B” in FIG. 23 (which isagain identified schematically and not necessarily spatially relative toother components of the apparatus 510), one or more additional layersmay be applied around the reinforcing layer 572 and/or other processingmay be completed, similar to the other embodiments described elsewhereherein. The resulting tubular device 580 may be wound onto uptake reel514, e.g., for further processing and/or incorporation into one or moretubular devices. For example, the tubular device 580 may be cut intoindividual tubular bodies and/or may have one or more components added(not shown) to provide a finished catheter, lead, or other tubulardevice, similar to other embodiments described elsewhere herein.

Alternatively, separate mandrels may be provided for the sleeve 550originating from the supply reel 512 and the coated liner 570 or tubulardevice 580 collected by the uptake reel 514. For example, FIG. 24 showsan apparatus 510′ that is generally similar to the apparatus 510 (wheresimilar elements are identified by similar numbers except with a′added). Unlike the apparatus 510, however, a mandrel is not shown beingremoved from the sleeve 550′ after it is cut by cutter 516.′ Forexample, the sleeve 550′ may be provided on supply reel 512′ without amandrel, although, alternatively, the sleeve 550′ may be carried by aseparate mandrel than mandrel 540′ or may be carried by the same mandrel540′ being separated from and merged again with the sleeve 550,′ similarto the previous embodiment.

Optionally, the supply and uptake mandrels may have different diametersor other cross-sections (not shown). For example, the uptake mandrel mayhave a larger diameter than the supply mandrel, e.g., to provide a gapbetween the opposing edges 559 of the reversed cut sleeve or coatedliner 570 when wrapped around the mandrel 540 (see FIG. 24C), or toallow multiple sleeves being fed around a single mandrel to provide asingle liner, e.g., similar to other embodiments described elsewhereherein.

In addition, apparatus 510′ in FIG. 24 includes one or more coatingdevices 520′ (one shown schematically), e.g., similar to the previousembodiments. Thus, the sleeve 550′ may be uncoated when wound ontosupply reel 512′ and coated before being cut by cutter 516.′ If thesleeve 550′ is carried on a mandrel (not shown) from the supply reel512,′ the mandrel may be removed after applying the coating with thecoating device(s) 520,′ e.g., after cutting the sleeve 550′ with thecutter 516,′ similar to the previous embodiment, but may be discarded orreused. Mandrel 540′ may be carried on a mandrel reel 524′ from whichthe mandrel 540′ may be fed substantially continuously towards the cutsleeve 560′ such that the reversed cut sleeve or coated liner 570′ iswrapped around the mandrel 540,′ similar to the previous embodiments. Asshown, the apparatus 510′ also includes a braiding device 522,′ whichmay wrap a reinforcing layer 572′ around the coated liner 570,′ e.g.,similar to other embodiments herein, to provide a tubular body 580,′which may be captured on uptake reel 514.′ The resulting tubular body580′ may be wound onto the uptake reel 514′ for subsequent processingand/or incorporation into one or more tubular devices, similar to theprevious embodiments.

Turning to FIGS. 25A-25E, alternative methods are shown for makingcoated liners, e.g., for catheters, leads, or other tubular devices.Generally, as shown in FIG. 25A, a sheet 650 may be initially providedthat includes an outer first surface 652, an inner second surface 654,and longitudinal edges 659 extending between first and second ends 656.The sheet 650 may be formed from thermoplastic or other material, suchas those described elsewhere herein.

As shown in FIGS. 25B and 25C, the sheet 650 may be secured around amandrel 640, e.g., such that the longitudinal edges 659 extend along alongitudinal axis 642 of the mandrel 640 and the first surface 652 isdisposed outwardly. For example, as shown in FIG. 26A, the mandrel 640may be a solid or hollow tubular body and the sheet 650 may be wrappedaround the outer surface 644 of the mandrel 640. The sheet 650 may besecured to the outer surface 644 of the mandrel 640 using one or morefeatures, such as one or more bands, clips, and the like (not shown). Inaddition or alternatively, the sheet 650 may be secured using a low tackadhesive or other material (not shown) applied to the outer surface 644of the mandrel 640 and/or to the second surface 654 of the sheet 650and/or at one or more locations along the longitudinal edges 659.

In an alternative embodiment, shown in FIG. 26B, a mandrel 640′ may beprovided that includes one or more slots for capturing the longitudinaledges 659 of the sheet 650. As shown, the mandrel 640′ has a “C” shapedcross-section, thereby defining a longitudinal slot 646′ defined byopposing edges 648′ that extend longitudinally along the mandrel 640.′The mandrel 640′ may be biased such that the edges 648′ abut or areclosely spaced apart from one another, yet the mandrel 640′ may besufficiently flexible to allow the edges 648′ to be moved apart from oneanother. For example, the edges 648′ may be moved apart to open the slot646,′ whereupon the longitudinal edges 659 of the sheet 650 may beintroduced into the slot 646.′ When the edges 648′ of the mandrel 640′are then released, the edges 648′ may engage the longitudinal edges 659of the sheet 650, thereby securing the sheet 659 around the mandrel640.′

In a further alternative, shown in FIG. 26C, a mandrel 640″ may beprovided that includes a convex surface region 645″ and a pair of ridges647″ sized to be engaged by clips 649.″ The ridges 647″ may extendsubstantially parallel to a longitudinal axis of the mandrel 640,″ e.g.,opposite the convex surface region 645.″ For example, as shown, thesheet 650 may be wrapped around the convex surface region 645″ of themandrel 640″ such that the longitudinal edges 659 of the sheet aredisposed over the ridges 647.″ The clips 649″ may be then be snapped orotherwise placed over the ridges 647″ to capture the longitudinal edges659 of the sheet 650 therebetween, thereby securing the sheet 659 to themandrel 640.″ Thus, in any of these alternatives, the sheet 650 may besecured to a mandrel 640 sufficiently tightly such that the firstsurface 652 of the sheet 650 is substantially smooth to accommodatereceiving a coating.

Turning to FIG. 25C, after securing the sheet 650 to the mandrel 640 (orthe other mandrels just described), a coating may be applied to thefirst surface 652 of the sheet 650. For example, as shown, the assemblyof the sheet 650 and mandrel 640 may be dipped in a reservoir of liquidcoating material 680 to apply the liquid coating material to the firstsurface 650. Alternatively, the coating may be applied using otherprocesses, such as spraying, brushing, rolling, and the like, similar toother embodiments herein. As shown in FIG. 25D, the coating material maybe cured, e.g., exposure to ultraviolet light 682, heating, air drying,and the like, similar to other embodiments herein.

Turning to FIG. 25E, once the coating is cured, the coated sheet 660 maythen be removed from mandrel 640. The coated sheet 660 may then beoriented with the coated first surface 652 disposed inwardly to provideone or more coated liners (not shown), similar to other embodimentsdescribed elsewhere herein. If the coated sheet 660 includes uncoatedregions, e.g., adjacent the longitudinal edges 659 due to being capturedby the mandrel 640,′ 640,″ the uncoated regions may be cut off orotherwise removed if desired. Alternatively, the uncoated edges 659 maybe attached together, e.g., by lapping or butting the edges 659 similarto other embodiments herein, to provide an enclosed sleeve with alongitudinal seam (not shown).

Alternatively, as shown in FIGS. 27A and 27B, an enclosed tube or sleeve650′ may be secured to a mandrel 640′ to facilitate coating a firstsurface 652′ of the sleeve 650.′ The sleeve 650′ may be formed usingmaterials and/or methods similar to any of the embodiments describedelsewhere herein, e.g., including a longitudinal seam (not shown). Themandrel 640″′ may include a convex outer surface 645′ opposite a ridgeor other feature 647′ that extend longitudinally along the mandrel640.′″ The sleeve 650′ may be received around the mandrel 640′ and aclip 649′ may be snapped or otherwise received over the ridge 647′ tocapture the sleeve 650′ therebetween, thereby securing the sleeve 650′to the mandrel 640′ and/or providing sufficient tension on the sleeve650′ to facilitate coating the first surface 652.′ The sleeve 650′ maythen be coated and separated from the mandrel 640′ similar to theprevious embodiment. The coated sleeve 650′ may then be reversed, or cutor otherwise separated into one or more coated sheets, similar to otherembodiments herein.

Optionally, similar to other embodiments herein, the reversed coatedsheet 660 (or coated sleeve 650′) may be incorporated into one or moretubular devices. For example, similar to other embodiments herein, thecoated sheet 660 of FIG. 25E may be wrapped around a mandrel (either thesame or different than mandrel 640), except with the coated surface 652oriented inwardly. One or more layers, e.g., a reinforcing layer, and/orouter tubular structure may be positioned and attached around the coatedsheet 660 to provide a catheter component, similar to the previousembodiments.

Turning to FIGS. 28A-28D, another exemplary method is shown for makingcoated liners using a mandrel 740 including first and second ends 741and an outer surface 744. The mandrel 740 may be a solid or tubularbody, e.g., having a cylindrical or other cross-section. The outersurface 744 may include a surface finish or coating to facilitateholding coating material thereon without allowing the coating materialto bond substantially to the outer surface 744.

As shown in FIG. 28A, the mandrel 740 may be dipped in a reservoir ofliquid coating material 780 to apply coating material 784 to the outersurface 744 of the mandrel 740, as shown in FIG. 28B. Alternatively, thecoating material 784 may be applied using other methods, such asspraying, rolling, brushing, and the like, similar to other embodimentsherein.

Turning to FIG. 28B, after applying the coating material, a substrate750 may be positioned over the mandrel 740 such that a first surface 752of the substrate 750 contacts the coating material 784. For example, thesubstrate 750 may be a sheet made from thermoplastic or other materialsimilar to other embodiments herein that is wrapped around the mandrel740 such that longitudinal edges (not shown) of the sheet are disposedadjacent one another. Alternatively, the substrate 750 may be anenclosed sleeve, which may be positioned around the mandrel 740 and thenshrunk, e.g., by heating, to cause the first surface 752 to contact thecoating material 784 and outer surface 744 of the mandrel 740.

Turning to FIG. 28C, with the substrate 750 positioned over the mandrel740, the coating material 784 may be cured through the substrate 750such that the coating material 784 bonds to the first surface 752 toprovide a coating having one or more desired properties, such as thosedescribed elsewhere herein. For example, as shown, a source ofultraviolet light 782 may be provided adjacent the substrate 750 to atleast partially cure the coating material 784. The substrate 750 may beat least partially transparent to the ultraviolet light such that atleast some of the ultraviolet light passes through the substrate 750 toat least partially cure the coating material 784. In addition oralternatively, other processes may be used to cure the coating material784 and/or bond the coating material 784 to the first surface of thesubstrate 750. For example, shrink tubing (not shown) may be positionedaround the substrate 750 and heat may be applied to heat the shrinktubing, substrate 750, and consequently the coating material 784. Theshrink tubing may also attempt to shrink when heated, thereby applyinginward pressure against the substrate 750 to enhance curing and/orbonding. In another option, vacuum may be applied, e.g., through one ormore ports in the outer surface 744 of the mandrel 740 to enhanceapposition of the substrate 750 against the coating material 784 andouter surface 744.

Turning to FIG. 28D, the mandrel 740 may then be removed from thesubstrate to provide a coated liner 770 having a coated inner surface752. For example, once the coating material is cured, the mandrel 740may simply be slid out of the substrate 750, e.g., if the substrate 750is a sleeve. Alternatively, if the substrate 750 is a sheet, the sheetmay be unwrapped from the mandrel 740. Optionally, similar to previousembodiments, one or more layers may be applied around the coated liner770, e.g., before or after removing the mandrel 740 to provide one ormore tubular bodies.

Turning to FIGS. 29A-29C, an alternative embodiment is shown forcreating a coating liner 870 by applying coating material 884 to amandrel 840. Unlike the previous embodiment, the mandrel 840 may be aplate including an outer surface 844, which may have a convex shape asshown, or alternatively, a concave, multiple curve, or substantiallyflat shape (not shown). As shown in FIG. 29A, coating material 884 maybe applied to the outer surface 844, and then a substrate 850, e.g., asheet, may be positioned against the mandrel 840 such that a firstsurface 852 of the substrate contacts the coating material 884 and outersurface 844, as shown in FIG. 29B. The coating material 884 may be curedand/or bonded to the first surface 852 of the substrate 850, and thenthe coated substrate 870 may be removed from the mandrel 840 to providea coated liner, which may be incorporated into one or more tubulardevices, similar to the previous embodiments.

In still another alternative, a sleeve or otherwise shaped reservoir ofsubstrate material may have one end sealed (not shown), and the sleevemay be filled with liquid coating material. If the sleeve is at leastpartially transparent to ultraviolet light, ultraviolet light may bedelivered through the sleeve to at least partially cure the coatingmaterial and/or bond the coating material to an inner surface of thesleeve. Once sufficiently cured, any remaining coating material may beremoved, and the resulting sleeve may be incorporated into one or moretubular device, similar to the previous embodiments.

The foregoing disclosure of the exemplary embodiments has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many variations and modifications of the embodiments described hereinwill be apparent to one of ordinary skill in the art in light of theabove disclosure.

Further, in describing representative embodiments, the specification mayhave presented the method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described. Asone of ordinary skill in the art would appreciate, other sequences ofsteps may be possible. Therefore, the particular order of the steps setforth in the specification should not be construed as limitations on theclaims.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. A method for making a tubular device sized for introduction into abody lumen, comprising: providing a sleeve comprising an outer firstsurface and an inner second surface extending between a first end and asecond end; coating the first surface with a coating to impart the firstsurface with one or more desired properties; cutting the coated sleevebetween the first and second ends to create opposing edges extendingbetween the first and second ends; reversing the cut sleeve such thatthe coated first surface defines an inner surface of the reversed cutsleeve and the opposing edges are disposed adjacent one another toprovide a coated liner; and attaching a tubular structure around thecoated liner, thereby providing a tubular device comprising an innersurface with the one or more desired properties.
 2. The method of claim1, wherein attaching a tubular structure around the coated linercomprises: positioning the coated liner over a mandrel such that theopposing edges are disposed adjacent one another; positioning thetubular structure over the coated liner; and attaching the tubularstructure to the coated liner.
 3. The method of claim 2, furthercomprising removing the mandrel after attaching the tubular structure tothe coated liner.
 4. The method of claim 2, wherein positioning thetubular structure over the coated liner comprises: applying areinforcing layer around the coated liner; and applying one or morelayers of material around the reinforcing layer.
 5. The method of claim4, wherein the reinforcing layer comprises at least one of a braidedstructure and a helical structure.
 6. The method of claim 4, furthercomprising heating at least one of the reinforcing layer and the coatedliner after applying the reinforcing layer and before applying the oneor more layers of material to attach the reinforcing layer to the coatedliner.
 7. The method of claim 6, wherein the sleeve comprisesthermoplastic material such that the coated liner reflows at leastpartially into the reinforcing layer during the heating step.
 8. Themethod of claim 1, wherein the coating comprises at least one ofhydrophilic material, an antithrombotic material, an antimicrobialmaterial, an anti-hemolytic material, and a drug-eluting material. 9.The method of claim 1, wherein the tubular structure is attached to thecoated liner using at least one of heat bonding, adhering with one ormore adhesives, and reflowing the tubular structure.
 10. The method ofclaim 1, further comprising attaching the opposing edges of the reversedcut to create a seam that extends between the first and second ends ofthe coated liner before attaching the tubular structure.
 11. The methodof claim 1, wherein the sleeve defines a longitudinal axis that extendsbetween the first and second ends, and wherein the coated sleeve is cutlongitudinally such that the opposing edges extend substantiallyparallel to the longitudinal axis.
 12. The method of claim 1, whereinthe sleeve is initially provided on a first mandrel before the coatedsleeve is cut, and wherein the first mandrel is removed before reversingthe cut sleeve.
 13. The method of claim 12, wherein the sleeve isinitially provided on the mandrel by extruding sleeve material onto themandrel.
 14. The method of claim 12, wherein reversing the cut sleevecomprises positioning the cut sleeve around a second mandrel with thecoated first surface disposed inwardly towards the second mandrel beforeattaching the tubular structure around the coated liner. 15-16.(canceled)
 17. A method for making tubular devices sized forintroduction into a body lumen, comprising: providing a thin-walledsleeve comprising an outer first surface and an inner second surfaceextending between a first end and a second end; coating the firstsurface with a coating to impart the first surface with one or moredesired properties; cutting the coated sleeve between the first andsecond ends to create opposing edges extending between the first andsecond ends; opening the coated sleeve by separating the opposing edges;and positioning the cut sleeve around an uptake mandrel to reverse thecut sleeve such that the coated first surface is oriented inwardlytowards the uptake mandrel and the opposing edges are disposed adjacentone another, thereby providing a coated liner.
 18. The method of claim17, further comprising attaching a tubular structure around the coatedliner, thereby providing a tubular device comprising an inner surfacewith the one or more desired properties. 19-22. (canceled)
 23. Themethod of claim 17, wherein the coating comprises at least one ofhydrophilic material, an antithrombotic material, an antimicrobialmaterial, an anti-hemolytic material, and a drug-eluting material.24-29. (canceled)
 30. A method for making a tubular device sized forintroduction into a body lumen, comprising: providing a thin-walledsheet comprising an outer first surface, an inner second surface, andlongitudinal edges extending between first and second ends; securing thesheet around a first mandrel such that the longitudinal edges extendalong a longitudinal axis of the first mandrel and the first surface isdisposed outwardly; applying a coating to the first surface of the sheetthat imparts the first surface with one or more desired properties;removing the coated sheet from the first mandrel; positioning the coatedsheet around a second mandrel such that the coated first surface isoriented inwardly towards the second mandrel and the longitudinal edgesare disposed adjacent one another; and attaching one or more layersaround the coated sheet to provide a catheter component. 31-34.(canceled)
 35. A method for making a tubular device sized forintroduction into a body lumen, comprising: providing a thin-walledsleeve comprising an outer first surface and an inner second surfaceextending between first and second ends; securing the sleeve around afirst mandrel such that the first surface is disposed outwardly; dippingthe sleeve and first mandrel into liquid coating material; curing theliquid coating material to create a coating on the first surface thatimparts the first surface with one or more desired properties; andremoving the coated sleeve from the first mandrel. 36-37. (canceled) 38.A method for making a tubular device sized for introduction into a bodylumen, comprising: providing a mandrel comprising a first end, a secondend, and an outer surface extending between the first and second ends;applying a coating material to the outer surface of the mandrel;positioning a substrate over the mandrel such that a first surface ofthe substrate contacts the coating material; curing the coating materialthrough the substrate such that the coating material bonds to the firstsurface to provide a coating having one or more desired properties.39-44. (canceled)